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[10-Q] Aspira Women's Health Inc. Quarterly Earnings Report

Filing Impact
(Neutral)
Filing Sentiment
(Neutral)
Form Type
10-Q
Rhea-AI Filing Summary

Aspira Women’s Health Inc. reported Q3 2025 results. Revenue was $2,305,000, with gross profit of $1,383,000. Operating expenses were $2,962,000, leading to a loss from operations of $1,579,000. A non-cash loss from the change in fair value of warrant liabilities of $4,309,000 drove total other (expense) income, net to $(3,313,000), and the company recorded a net loss of $4,892,000 for the quarter.

For the nine months ended September 30, 2025, revenue was $6,988,000 and net loss was $9,411,000. Cash and cash equivalents were $3,809,000, working capital was $1,626,000, and long-term debt (DECD loan) was $1,100,000. Warrant liabilities increased to $5,280,000, largely tied to March 2025 warrants measured at fair value. Financing during 2025 included $3,484,000 in gross proceeds under the 2024 at-the-market program and $2,949,000 in gross proceeds from a September 2025 private placement.

The company disclosed substantial doubt about its ability to continue as a going concern within one year. Its common stock was delisted from Nasdaq in April 2025 and began trading on the OTC QX Best Market on October 14, 2025.

Positive
  • None.
Negative
  • Going concern: management disclosed substantial doubt about continuing operations within one year.
  • Delisting: shares were delisted from Nasdaq in April 2025 and moved to OTC QX in October 2025.
  • Warrant liabilities: liability increased to $5,280,000, adding significant non-cash volatility.
  • Ongoing losses: Q3 net loss of $4,892,000; nine-month net loss of $9,411,000.

Insights

Non-cash warrant revaluation and liquidity risk drove Q3 loss.

Aspira posted Q3 revenue of $2,305,000 and a net loss of $4,892,000. The quarter was heavily affected by a non-cash loss from the change in fair value of warrant liabilities of $4,309,000, tied to the March 2025 warrants now carried as liabilities. Operating expenses declined year over year (Q3 total $2,962,000 vs. $5,099,000), improving the operating loss to $(1,579,000).

Liquidity remains tight: cash was $3,809,000 with working capital of $1,626,000. The company raised $3,484,000 via its 2024 ATM and $2,949,000 through a September 2025 private placement; financing cash inflows for the nine months totaled $7,481,000. The DECD loan stood at $1,100,000 long-term. Management disclosed substantial doubt about continued operations within one year.

Other items affected results: nine-month other income included $1,500,000 from ARPA‑H Milestone 2 and $1,013,000 of Employee Retention Tax Credits, while ARPA‑H later terminated the contract after Milestone 3. The shares were delisted from Nasdaq in April 2025 and moved to OTC QX on October 14, 2025. Subsequent activity will depend on revenue trajectory and access to capital under existing or new facilities.

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Table of Contents

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2025

OR

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ______ to ______

Commission File Number: 001-34810

Aspira Women’s Health Inc.

(Exact name of registrant as specified in its charter)

Delaware

 

33-0595156

(State or other jurisdiction of incorporation or
organization)

 

(I.R.S. Employer Identification No.)

 

 

 

12117 Bee Caves Road, Building III, Suite 100,
Austin, Texas

 

78738

(Address of principal executive offices)

 

(Zip Code)

Registrant’s telephone number, including area code: (512) 519-0400

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

    

Trading Symbol(s)

    

Name of each exchange on which registered

Common Stock, par value $0.001 per share

 

AWHL

 

The OTC QX Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes No

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer

Accelerated filer

 

Non-accelerated filer

Smaller reporting company

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes No

As of November 13, 2025, the registrant had 42,655,918 shares of common stock, par value $0.001 per share, outstanding.

Table of Contents

ASPIRA WOMEN’S HEALTH INC.

FORM 10-Q

For the Quarter Ended September 30, 2025

Table of Contents

Page

PART I

Financial Information

1

Item 1

Financial Statements (unaudited)

1

Condensed Consolidated Balance Sheets as of September 30, 2025 and December 31, 2024

1

Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2025 and 2024

2

Condensed Consolidated Statements of Changes in Stockholders’ Deficit for the three and nine months ended September 30, 2025 and 2024

3

Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2025 and 2024

5

Notes to Condensed Consolidated Financial Statements

6

Item 2

Management’s Discussion and Analysis of Financial Condition and Results of Operations

27

Item 3

Quantitative and Qualitative Disclosures About Market Risk

41

Item 4

Controls and Procedures

41

PART II

Other Information

43

Item 1

Legal Proceedings

43

Item 1A

Risk Factors

43

Item 2

Unregistered Sales of Equity Securities and Use of Proceeds

43

Item 3

Defaults Upon Senior Securities

43

Item 4

Mine Safety Disclosures

43

Item 5

Other Information

43

Item 6

Exhibits

44

SIGNATURES

45

The following are registered and unregistered trademarks and service marks of Aspira Women’s Health Inc.: VERMILLION SM, ASPIRA WOMEN’S HEALTH®, OVA1®, OVERA®, ASPIRA LABS ®, OVACALC®, OVASUITESM, ASPIRA GENETIXSM, OVA1PLUS®, OVAWATCH®, ENDOCHECKSM, ENDOINFORMTM, OVAINFORMTM, OVAINHERITSM, ASPIRA SYNERGY®, OVA360SM, ASPIRA IVDSM, AND YOUR HEALTH, OUR PASSION®.

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PART I - FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS

Aspira Women’s Health Inc.

Condensed Consolidated Balance Sheets (unaudited)

(Amounts in Thousands, Except Share and Par Value Amounts)

September 30, 

December 31, 

    

2025

    

2024

Assets

 

  

 

  

Current assets:

 

  

 

  

Cash and cash equivalents

$

3,809

$

1,769

Accounts receivable, net of reserves of $0

 

1,317

 

990

Prepaid expenses and other current assets

 

417

 

1,098

Inventories

 

282

 

326

Total current assets

 

5,825

 

4,183

Property and equipment, net

 

44

 

69

Intangible assets, net

343

-

Right-of-use assets

 

1,029

 

1,194

Other assets

 

55

 

45

Total assets

$

7,296

$

5,491

Liabilities and Stockholders’ Deficit

 

 

  

Current liabilities:

 

 

  

Accounts payable

$

1,811

$

2,173

Accrued liabilities

 

1,967

 

2,445

Current portion of long-term debt

 

234

 

229

Short-term debt

 

-

 

614

Current maturities of lease liabilities

 

187

 

7

Total current liabilities

 

4,199

 

5,468

Non-current liabilities:

 

 

  

Long-term debt

 

1,100

 

1,278

Non-current maturities of lease liabilities

 

1,061

 

1,248

Warrant liabilities

 

5,280

 

60

Total liabilities

 

11,640

 

8,054

Commitments and contingencies (Note 5)

 

 

  

Stockholders’ deficit:

 

 

  

Preferred stock, par value $0.001 per share, 5,000,000 shares authorized; no shares issued and outstanding at September 30, 2025 and December 31, 2024

-

-

Common stock, par value $0.001 per share, 200,000,000 shares authorized at September 30, 2025 and December 31, 2024; 42,655,918 and 17,407,120 shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively

 

43

 

17

Additional paid-in capital

 

536,421

 

528,817

Accumulated deficit

 

(540,808)

 

(531,397)

Total stockholders’ deficit

 

(4,344)

 

(2,563)

Total liabilities and stockholders’ deficit

$

7,296

$

5,491

See accompanying notes to the unaudited condensed consolidated financial statements.

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Aspira Women’s Health Inc.

Condensed Consolidated Statements of Operations (unaudited)

(Amounts in Thousands, Except Share and Per Share Amounts)

Three Months Ended

Nine Months Ended

September 30, 

September 30, 

    

2025

    

2024

    

2025

    

2024

Revenue:

 

  

 

  

 

  

 

  

Product

$

2,305

$

2,257

$

6,988

$

6,833

Total revenue

 

2,305

 

2,257

 

6,988

 

6,833

Cost of revenue:

 

 

 

 

Product

 

922

 

902

 

2,511

 

2,843

Total cost of revenue

 

922

 

902

 

2,511

 

2,843

Gross profit

 

1,383

 

1,355

 

4,477

 

3,990

Operating expenses:

 

 

 

 

Research and development

 

739

 

908

 

2,416

 

2,766

Sales and marketing

 

683

 

2,143

 

2,448

 

6,169

General and administrative

 

1,540

 

2,048

 

6,242

 

7,902

Total operating expenses

 

2,962

 

5,099

 

11,106

 

16,837

Loss from operations

 

(1,579)

 

(3,744)

 

(6,629)

 

(12,847)

Other (expense) income, net:

 

 

 

 

Change in fair value of warrant liabilities

 

(4,309)

 

174

 

(4,012)

 

1,314

Change in fair value of convertible notes

 

-

 

-

 

170

 

-

Loss upon issuance of Convertible Notes carried at fair value

 

-

 

-

 

(1,198)

 

-

Interest expense, net

 

(13)

 

(5)

 

(40)

 

(20)

Other income (expense), net

 

1,009

 

28

 

2,298

 

(153)

Total other (expense) income, net

 

(3,313)

 

197

 

(2,782)

 

1,141

Net loss

$

(4,892)

$

(3,547)

$

(9,411)

$

(11,706)

Net loss per share - basic and diluted

$

(0.13)

$

(0.23)

$

(0.30)

$

(0.88)

Weighted average common shares used to compute basic and diluted net loss per common share

36,388,370

15,405,672

31,203,821

13,269,646

See accompanying notes to the unaudited condensed consolidated financial statements.

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Aspira Women’s Health Inc.

Condensed Consolidated Statements of Changes in Stockholders’ Deficit (unaudited)

(Amounts in Thousands, Except Share Amounts)

    

Common Stock

    

    

    

    

Additional

Total

Paid-In

Accumulated

Stockholders’

Shares

Amount

Capital

Deficit

Equity (Deficit)

Balance at December 31, 2024

 

17,407,120

$

17

$

528,817

$

(531,397)

$

(2,563)

Net loss

 

-

 

-

 

-

 

(1,853)

 

(1,853)

Common stock issued under 2024 At-the-Market Offering Agreement, net of issuance costs

 

12,277,441

 

12

 

3,325

 

-

 

3,337

Common stock issued for convertible notes settlement

 

5,465,850

 

6

 

910

 

-

 

916

Common stock issued for vested restricted stock awards

 

79,687

 

-

 

37

 

-

 

37

Stock-based compensation expense

 

-

 

-

 

66

 

-

 

66

Balance at March 31, 2025

 

35,230,098

 

35

 

533,155

 

(533,250)

 

(60)

Net loss

 

-

 

-

 

-

 

(2,666)

 

(2,666)

Common stock issued under 2024 Equity Line of Credit Agreement, net of issuance costs

 

354,988

 

1

 

24

 

-

 

25

Common stock issued for vested restricted stock awards

 

52,239

 

-

 

45

 

-

 

45

Stock-based compensation expense

 

-

 

-

 

(29)

 

-

 

(29)

Balance at June 30, 2025

 

35,637,325

36

533,195

(535,916)

(2,685)

Net loss

-

-

-

(4,892)

(4,892)

Common stock issued under September 2025 Private Placement Offering, net of issuance costs

6,550,000

7

2,808

-

2,815

Common stock issued for exercised warrants

450,000

-

381

-

381

Common stock issued for vested restricted stock awards

18,593

-

20

-

20

Stock-based compensation expense

-

-

17

-

17

Balance at September 30, 2025

 

42,655,918

$

43

$

536,421

$

(540,808)

$

(4,344)

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Aspira Women’s Health Inc.

Condensed Consolidated Statements of Changes in Stockholders’ Deficit (unaudited) (continued)

(Amounts in Thousands, Except Share Amounts)

    

Common Stock

    

    

    

    

Additional

Total

Paid-In

Accumulated

Stockholders’

Shares

Amount

Capital

Deficit

Deficit

Balance at December 31, 2023

 

10,645,049

 

11

 

515,927

 

(518,303)

 

(2,365)

Net loss

 

-

 

-

 

-

 

(4,629)

 

(4,629)

Common stock issued under 2023 Equity Line of Credit Agreement

 

111,369

 

-

 

400

 

-

 

400

Common stock issued under 2024 Direct Offering, net of issuance costs

 

1,371,000

 

1

 

4,868

 

-

 

4,869

Warrant Exercise

 

200,000

 

-

 

-

 

-

 

-

Common stock issued for vested restricted stock awards

 

16,686

 

-

 

-

 

-

 

-

Stock-based compensation expense

 

-

 

-

 

362

 

-

 

362

Balance at March 31, 2024

 

12,344,104

 

12

 

521,557

 

(522,932)

 

(1,363)

Net loss

 

-

 

-

 

-

 

(3,530)

 

(3,530)

Issuance costs related to common stock issued under 2024 Direct Offering

 

-

 

-

 

(39)

 

-

 

(39)

Common stock issued under 2023 Equity Line of Credit Agreement

 

475,986

 

1

 

1,100

 

-

 

1,101

Common stock issued for vested restricted stock awards

 

5,000

 

-

 

16

 

-

 

16

Stock-based compensation expense

 

-

 

-

 

106

 

-

 

106

Balance at June 30, 2024

 

12,825,090

13

522,740

(526,462)

(3,709)

Net loss

-

-

-

(3,547)

(3,547)

Common stock issued under 2023 Equity Line of Credit Agreement

362,219

-

400

-

400

Common stock issued under Warrant Inducement Agreement, net of issuance costs

1,711,111

2

1,860

-

1,862

Reclassification of Warrant Liability upon Exercise

-

-

245

-

245

Common stock issued under 2024 Private Placement Offering, net of issuance costs

1,248,527

1

1,837

-

1,838

Common stock issued under 2024 Securities Purchase Agreements

9,733

-

11

-

11

Common stock issued for vested restricted stock awards

127,701

-

145

-

145

Stock-based compensation expense

-

-

235

-

235

Balance at September 30, 2024

 

16,284,381

$

16

$

527,473

$

(530,009)

$

(2,520)

See accompanying notes to the unaudited condensed consolidated financial statements.

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Aspira Women’s Health Inc.

Condensed Consolidated Statements of Cash Flows (unaudited)

(Amounts in Thousands)

Nine Months Ended

September 30, 

    

2025

    

2024

Cash flows from operating activities:

 

  

 

  

Net loss

$

(9,411)

$

(11,706)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

  

Non-cash lease expense

 

158

 

6

Depreciation and amortization

 

74

 

78

Stock-based compensation expense

 

155

 

864

Change in fair value of warrant liabilities

 

4,012

 

(1,314)

Change in fair value of Convertible Notes

(170)

25

Loss upon issuance of Convertible Notes carried at fair value

1,198

-

Loss on impairment and disposal of property and equipment

 

1

 

-

Changes in operating assets and liabilities:

 

 

  

Accounts receivable

 

(327)

 

205

Prepaid expenses and other assets

 

671

 

560

Inventories

 

44

 

(63)

Accounts payable

 

(362)

 

1,290

Accrued liabilities

 

(478)

 

(369)

Other liabilities

 

(613)

 

(668)

Net cash used in operating activities

 

(5,048)

 

(11,092)

Cash flows from investing activities:

 

  

 

  

Purchase of property and equipment

 

(8)

 

(37)

Purchase of intangible assets

(385)

-

Net cash used in investing activities

 

(393)

 

(37)

Cash flows from financing activities:

 

  

 

  

Principal repayment of DECD loan

 

(174)

 

(35)

Proceeds from 2023 Equity Line of Credit Agreement

 

-

 

1,901

Proceeds from 2024 Direct Offering

 

-

 

5,563

Payment of issuance costs for 2024 Direct Offering

 

-

 

(733)

Proceeds from Warrant Inducement Agreement

 

-

 

2,139

Payment of issuance costs for Warrant Inducement Agreement

 

-

 

(277)

Proceeds from 2024 Securities Purchase Agreements

 

-

 

11

Proceeds from 2024 At the Market Offering Agreement

 

3,484

 

-

Payment of issuance costs for 2024 At the Market Offering Agreement

 

(147)

 

-

Proceeds from 2024 Private Placement Offering

 

-

 

1,910

Payment of issuance costs for 2024 Private Placement Offering

 

-

 

(72)

Proceeds from 2025 Private Placement Offering

2,949

-

Payment of issuance costs for 2025 Private Placement Offering

(134)

-

Proceeds from issuance of common stock from exercise of warrants

112

-

Proceeds from Convertible Notes

1,366

-

Proceeds from Equity Line of Credit

25

-

Net cash provided by financing activities

 

7,481

 

10,407

Net decrease in cash, cash equivalents and restricted cash

 

2,040

 

(722)

Cash, cash equivalents and restricted cash, beginning of year

 

1,769

 

2,855

Cash, cash equivalents and restricted cash, end of year

$

3,809

$

2,133

Supplemental disclosure of cash flow information:

 

  

 

  

Cash paid for interest

$

26

$

43

Supplemental disclosure of noncash investing and financing activities:

 

  

 

  

Increase in right-of-use assets

$

-

$

169

Fair value of warrants issued in conjunction with Warrant Inducement Agreement

$

-

$

1,323

Fair value of warrants issued upon conversion of Convertible Notes

$

1,477

$

-

Fair value of common stock issued upon conversion of Convertible Notes

$

916

$

-

See accompanying notes to the unaudited condensed consolidated financial statements.

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Aspira Women’s Health Inc.

Notes to Condensed Consolidated Financial Statements

(Unaudited)

1. ORGANIZATION, BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING AND REPORTING POLICIES

Organization

Aspira Women’s Health Inc. (“Aspira” and its wholly-owned subsidiaries are collectively referred to as the “Company”) is incorporated in the state of Delaware, and is engaged in the business of developing and commercializing diagnostic tests for gynecologic disease. The Company currently markets and sells the following products and related services: (1) the Ova1Plus workflow, which uses Ova1, a qualitative serum test intended as an aid to further assess the likelihood of malignancy in women with an ovarian adnexal mass for which surgery is planned when the physician’s independent clinical and radiological evaluation does not indicate malignancy, as the primary test and Overa, a second-generation biomarker test intended to maintain Ova1’s high sensitivity while improving specificity, as a reflex for Ova1 intermediate range results, leveraging the strengths of Ova1’s MIA sensitivity and Overa’s MIA2G specificity to reduce incorrectly elevated results; and (2) OvaWatch, a lab developed test (“LDT”) intended to assist in the initial clinical assessment of malignancy risk in all women thought to have an indeterminate or benign adnexal mass. Overa is currently not offered except as a reflex test performed as part of the Ova1Plus workflow. Collectively, these tests are referred to and marketed as OvaSuite. The Company’s products are distributed through its own national sales force, through its proprietary, decentralized testing platform and cloud service marketed as Aspira Synergy, and through marketing and distribution agreements with BioReference Health, LLC and ARUP Laboratories.

Going Concern and Liquidity

As of September 30, 2025, the Company had approximately $3,809,000 of cash and cash equivalents, an accumulated deficit of approximately $540,808,000, and working capital of approximately $1,626,000. For the nine months ended September 30, 2025, the Company incurred a net loss of $9,411,000 and used cash in operations of $5,048,000. The Company has incurred significant net losses and negative cash flows from operations since inception. The Company also expects to continue to incur a net loss and negative cash flows from operations for the remainder of 2025. In order to fund operations, meet its capital requirements or satisfy the anticipated obligations as they become due, the Company expects to take further action to protect its liquidity position, which include, but are not limited to:

Raising capital through an equity offering via a private placement offering, to the extent that the Company raises additional funds by issuing equity securities, the Company’s stockholders may experience significant dilution. However, no assurance can be given that capital will be available on acceptable terms, or at all;
Securing debt, however, no assurance can be given that debt will be available on acceptable terms or at all;
Reducing executive bonuses or replacing cash compensation with equity grants;
Reducing professional services and consulting fees and eliminating non-critical projects;
Reducing travel and entertainment expenses; and
Reducing, eliminating or deferring discretionary marketing programs.

The Company also has outstanding warrants to purchase shares of its common stock that may be exercised although there can be no assurance that the warrants will be exercised.

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There can be no assurance that the Company will achieve or sustain profitability or positive cash flow from operations. Management expects cash from product sales and licensing to be the Company’s only material, recurring source of cash in 2025. Given the above conditions, there is substantial doubt about the Company’s ability to continue as a going concern within one year after the date these consolidated interim financial statements are filed. The unaudited condensed consolidated financial statements have been prepared on a going concern basis and do not include any adjustments that might result from these uncertainties.

2025 Delisting from Nasdaq

On April 15, 2025, the Company received written notice from the Office of General Counsel of The Nasdaq Stock Market (“Nasdaq”) indicating that the Nasdaq Hearings Panel determined to delist the Company’s shares from Nasdaq due to the Company’s failure to meet Nasdaq’s continued listing standard under Nasdaq Listing Rule 5550(b)(1), which required the Company to maintain a minimum of $2.5 million in stockholders’ equity for continued listing on the Nasdaq Capital Market. The Company’s common stock was traded on the OTC Markets Group effective at the open of trading on April 17, 2025 under the symbol “AWHL.” Effective October 14. 2025, the Company’s common stock began trading on the OTC QX Best Market.

Basis of Presentation

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 8-03 of Regulation S-X. Accordingly, they do not include all of the information and notes required by GAAP for complete financial statements. In the opinion of management of the Company, all adjustments, consisting of normal recurring adjustments necessary for the fair statement of results for the periods presented, have been included. The results of operations of any interim period are not necessarily indicative of the results of operations for the full year or any other interim period.

The unaudited condensed consolidated financial statements and related disclosures have been prepared with the presumption that users of the unaudited condensed consolidated financial statements have read or have access to the audited consolidated financial statements for the preceding fiscal year. The consolidated balance sheet at December 31, 2024 included in this report has been derived from the audited consolidated financial statements at that date but does not include all the information and notes required by GAAP. Accordingly, these unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto for the year ended December 31, 2024, included in the Company’s Annual Report on Form 10-K, filed with the SEC on March 27, 2025.

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimated results.

Significant Accounting Policies

Revenue Recognition

Product Revenue – OvaSuite: The Company recognizes product revenue in accordance with the provisions of ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”). Product revenue is recognized upon completion of the OvaSuite test and delivery of results to the physician based on estimates of amounts that will ultimately be realized. In determining the amount of revenue to be recognized for a delivered test result, the Company considers factors such as payment history and amount, payer coverage, whether there is a reimbursement contract between the payer and the Company, and any developments or changes that could impact reimbursement. These estimates require significant judgment by management as the collection cycle on some accounts can be as long as one year. The effect of any change made to an estimated input component and, therefore revenue recognized, would be recorded as a change in estimate at the time of the change.

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The Company also reviews its patient account population and determines an appropriate distribution of patient accounts by payer (i.e., Medicare, patient pay, other third-party payer, etc.) into portfolios with similar collection experience. The Company has elected this practical expedient that, when evaluated for collectability, results in a materially consistent revenue amount for such portfolios as if each patient account were evaluated on an individual contract basis. During the three and nine months ended September 30, 2025, there were no adjustments to estimates of variable consideration to derecognize revenue for services provided in a prior period; however, there was additional revenue recognized related to prior quarters of $89,000 and $311,000 for the three and nine months ended September 30, 2025, respectively. There were no impairment losses on accounts receivable recorded during the three and nine months ended September 30, 2025.

Accounts Receivable: Virtually all accounts receivable are derived from sales made to customers located in North America. The Company grants credit to customers in the normal course of business and the resulting trade receivables are stated at their net realizable value. The Company maintains an allowance for credit losses based upon the expected collectability of accounts receivable, including the historical collection cycle. Amounts are written off against the allowances for credit losses when the Company determines that a customer account is not collectable. The Company believes its exposure to concentrations of credit risk is limited due to the diversity of its payer base.

Common Stock Warrants: The Company accounts for common stock warrants as either equity-classified or liability-classified instruments based on an assessment of the specific terms of the warrants and applicable authoritative guidance in Financial Accounting Standards Board Accounting Standards Codification (“ASC”) 480, Distinguishing Liabilities from Equity (“ASC 480”) and ASC 815-40, Contracts in Entity’s Own Equity (“ASC 815-40”). The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and meet all of the requirements for equity classification under ASC 815-40. The requirements for equity classification are that they (1) are freestanding financial instruments that are legally detachable and separately exercisable from the common stock, (2) do not embody an obligation for the Company to repurchase its shares, (3) permit the holder to receive a fixed number of shares of common stock upon exercise and (4) are indexed to the Company’s common stock. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and each subsequent reporting period. Warrants that meet all of the criteria for equity classification are recorded as a component of additional paid-in capital at the time of issuance and are not remeasured. Warrants that do not meet the required criteria for equity classification are classified as liabilities. The Company adjusts such warrants to fair value at each reporting period until the warrants are exercised or expire. Any change in fair value is recognized in Change in fair value of warrant liabilities on the Company’s statement of operations.

Segment Reporting

The Company’s Chief Operating Decision Maker (“CODM”) is its Chief Executive Officer, who reviews financial information presented on a consolidated basis for purposes of allocating resources and assessing financial performance. The Company views its operations and manages its business in a single operating segment, which is the discovery, development, and commercialization of noninvasive diagnostic tests. As a result, the CODM evaluates the business on a consolidated basis. The Company’s CODM uses the net loss that is reported on the Company’s consolidated statement of operations as a consolidated net loss for the purpose of allocating resources. The Company also monitors its cash and cash equivalents as reported on its consolidated balance sheets to determine its liquidity needs and to allocate resources.

The accounting policies of the Company’s single segment are the same as those described in this summary of significant accounting policies. The CODM assesses the performance of the Company’s single segment and decides how to allocate resources based on consolidated net income. Under the current organizational structure, this measure is not discreetly available or required individually for any of the Company’s business activities and is only available at the consolidated level. The monitoring of budgeted versus actual results are used in assessing performance of the Company’s single segment, allocating resources and in establishing management’s compensation. The measure of segment assets is reported on the consolidated balance sheet as total consolidated assets. Consolidated revenue does not include any inter-segment sales or transfers.

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The following table summarizes financial statement line items regularly reviewed by the CODM (in thousands).

    

Three Months Ended

    

Nine Months Ended

September 30, 

September 30, 

(in thousands)

2025

    

2024

2025

    

2024

Total Assets

$

7,296

$

4,759

$

7,296

$

4,759

Total Revenue

2,305

2,257

6,988

6,833

Less:

Personnel costs

(1,635)

(3,294)

(5,767)

(10,277)

Professional fees

(721)

(3,287)

(1,075)

(3,986)

Postage and kit costs

(346)

(297)

(1,029)

(1,029)

Travel expenses

(57)

(250)

(176)

(734)

Lab related expenses

(414)

(339)

(1,185)

(1,038)

Software licenses and maintenance costs

(209)

(199)

(560)

(594)

Other segment item(1)

(502)

1,665

(3,825)

(2,022)

Other (expense) income, net

(3,313)

 

197

 

(2,782)

 

1,141

Net Loss

$

(4,892)

$

(3,547)

$

(9,411)

$

(11,706)

(1) Other segment items include overhead costs, insurance expenses, IT expenses and depreciation.

Property and Equipment

 

Property and equipment are carried at cost less accumulated depreciation and amortization. Property and equipment are depreciated when placed into service using the straight-line method over the estimated useful lives, generally three to five years. Leasehold improvements are amortized using the straight-line method over the shorter of the estimated useful life of the asset or the remaining term of the lease. Maintenance and repairs are charged to operations as incurred. Upon sale or retirement of assets, the cost and related accumulated depreciation are removed from the balance sheet and the resulting gain or loss is reflected in operations.

 

Property and equipment are reviewed for impairment when events or changes in circumstances indicate the carrying amount of an asset may not be recoverable. If property and equipment are considered to be impaired, an impairment loss is recognized.

Intangible Assets

 

Intangible assets are carried at cost less accumulated depreciation and amortization. Intangible assets are amortized when placed into service using the straight-line method over the estimated useful lives. Upon sale or retirement of assets, the cost and related accumulated depreciation are removed from the balance sheet and the resulting gain or loss is reflected in operations.

 

Intangible assets are reviewed for impairment when events or changes in circumstances indicate the carrying amount of an asset may not be recoverable. If Intangible assets are considered to be impaired, an impairment loss is recognized.

Recent Accounting Pronouncements

Standards Adopted

In June 2022, the FASB issued ASU No. 2022-03, Fair Value Measurement (Topic 820): Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions (“ASU 2022-03”) to clarify guidance in Topic 820 on the fair value measurement of an equity security that is subject to a contractual sale restriction and also requires specific disclosures related to an equity security. ASU 2022-03 was effective for fiscal years beginning after December 15,

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2024, including interim periods within those fiscal years. The Company adopted ASU 2022-03 on January 1, 2025. The adoption of this standard did not have a material impact on the Company’s consolidated results of operations, financial position, or cash flows.

In March 2023, the FASB issued ASU No. 2023-01, Leases (Topic 842): Common Control Arrangements (“ASU 2023-01”). ASU 2023-01 clarified the accounting for leasehold improvements for leases under common control. The guidance is scheduled to be effective for fiscal years beginning after December 15, 2024, including interim periods within those fiscal years. Early adoption is permitted. ASU 2023-01 was adopted by the Company on January 1, 2025. The adoption of this standard did not have a material impact on the Company’s consolidated results of operations, financial position, or cash flows.

In October 2023, the FASB issued ASU No. 2023-06, Disclosure Improvements: Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative (“ASU 2023-06”). The amendments in this ASU are expected to clarify or improve disclosure and presentation requirements of a variety of ASC topics by aligning them with the SEC’s regulations. ASU 2023-06 will become effective for each amendment on the effective date of the SEC’s corresponding disclosure rule changes. The Company adopted ASU 2023-06 on January 1, 2025. The adoption of this standard did not have a material impact on the Company’s consolidated results of operations, financial position, or cash flows.

In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures (“ASU 2023-07”) to update reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses and information used to assess segment performance. This ASU requires disclosure of significant segment expenses that are regularly provided to the CODM and included within the reported measure of a segment’s profit or loss, requires interim disclosures about a reportable segment’s profit or loss and assets that are currently required annually, requires disclosure of the position and title of the CODM, clarifies circumstances in which an entity can disclose multiple segment measures of profit or loss, and contains other disclosure requirements. ASU 2023-07 was adopted by the Company on January 1, 2024. The adoption of this standard did not have a material impact on the Company’s consolidated results of operations, financial position, or cash flows.

Standards Yet to be Adopted

In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”) that addresses requests for improved income tax disclosures from investors that use the financial statements to make capital allocation decisions. Public entities must adopt the new guidance for fiscal years beginning after December 15, 2024. The amendments in this ASU must be applied on a retrospective basis to all prior periods presented in the financial statements and early adoption is permitted. The Company is still evaluating whether the adoption of ASU 2023-09 will have a material impact on the Company’s consolidated results of operations, financial position, or cash flows.

In November 2024, the FASB issued ASU No. 2024-03, Income Statement – Reporting Comprehensive Income-Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses (“ASU 2024-03”) that requires disaggregation of certain expense captions into specified categories in disclosures within the footnotes to the financial statements. The standard will become effective for annual periods beginning after December 15, 2026. The Company is still evaluating whether the adoption of ASU 2024-03 will have a material impact on its results of operations, financial position or cash flows.

In July 2025, the FASB issued ASU No. 2025-05, Measurement of Credit Losses for Accounts Receivable and Contract Assets (“ASU 2025-05”) to reduce the complexity of applying credit losses under ASC 326-320. ASU 2025-05 provides a practical expedient permitting an entity to assume current conditions as of the balance sheet date that do not change for the remaining life of the current accounts receivable and current contract assets. ASU 2025-05 also provides for an accounting election which allows an entity to consider cash collection activity after the balance sheet date when estimating expected credit losses on current accounts receivable and current contract assets. The standard will become effective for annual periods beginning after December 15, 2025.  The Company is still evaluating whether the adoption of

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ASU 2023-09 will have a material impact on the Company’s consolidated results of operations, financial position, or cash flows.

2. FAIR VALUE MEASUREMENTS

Fair Value of Financial Instruments

Cash and cash equivalents, accounts receivable, and accounts payable are considered Level 1 due to their short-term nature and their market interest rates.

The Company recorded warrants in connection with a public offering in 2022 (the “2022 Warrants”) in warrant liabilities. As discussed in Note 6 to the unaudited condensed consolidated financial statements, in connection with a registered direct offering in 2024, the Company amended certain of the 2022 Warrants to purchase up to an aggregate of 366,664 shares of common stock (the “2022 Modified Warrants”). The terms of the remaining 433,321 of the 2022 Warrants were unchanged (the “2022 Unmodified Warrants”). In August 2024, 311,111 of the 2022 Modified Warrants were further modified as part of a warrant inducement agreement. These warrants were exercised at a reduced price of $1.25.

The fair value of the 2022 Warrants as of September 30, 2025 and December 31, 2024 was approximately $66,000 and $60,000, respectively. The fair value of the 2022 Warrants was estimated using Black-Scholes pricing model based on the following assumptions:

    

September 30, 2025

    

December 31, 2024

 

Unmodified

Modified

Unmodified

Modified

 

Warrants

Warrants

Warrants

Warrants

 

Dividend yield

 

-

%

-

%

-

%

-

%

Volatility

 

162.3

%

145.1

%

111.3

%

103.6

%

Risk-free interest rate

 

3.61

%

3.65

%

4.22

%

4.28

%

Expected lives (years)

 

1.89

 

3.33

 

2.64

 

4.07

Weighted average fair value

$

0.117

$

0.281

$

0.101

$

0.162

The 2022 Warrants were deemed to be derivative instruments due to certain contingent put features. The fair value of the 2022 Warrants was determined using the Black-Scholes option pricing model, deemed to be an appropriate model due to the terms of the 2022 Warrants issued, including a fixed term and exercise price.

The fair value of the 2022 Warrants was affected by changes in inputs to the Black-Scholes option pricing model including the Company’s stock price, expected stock price volatility, the contractual term, and the risk-free interest rate. This model uses Level 2 inputs, including stock price volatility, in the fair value hierarchy established by ASC 820, Fair Value Measurement. The 2022 Warrants are classified in warrant liabilities on the Company’s unaudited condensed consolidated balance sheets.

The Company recorded warrants in connection with the March conversion of Senior Secured Convertible Promissory Notes (the “Convertible Notes”) in 2025 (the “March 2025 Warrants”) in warrant liabilities. The March 2025 Warrants were deemed to be derivative instruments due to certain contingent put features. As discussed in Note 5 to the unaudited condensed consolidated financial statements, in connection with the conversion of convertible notes in March 2025, the Company issued warrants to purchase up to an aggregate of 12,298,177 shares of common stock. The March 2025 Warrants had an exercise price of $0.25 per share for the first 24 months after issuance, and $0.50 per share thereafter, but were modified in September 2025 to an exercise price of $0.35 per share (the “Amended March 2025 Warrants”), utilizing a fixed expiration date.

The fair value of the March 2025 Warrants as of September 30, 2025 and March 12, 2025 was approximately $5,213,000 and $1,477,000, respectively. The fair value of the March 2025 Warrants was estimated using a Monte Carlo simulation pricing model for its March 12, 2025 fair value assessment, which uses Level 3 inputs due to its incorporation

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of significant inputs that are not observable in the market. The mean present value across multiple simulation iterations was used to estimate the fair value of the March 2025 Warrants.

Following the modification, the fair value of the Amended March 2025 Warrants was determined using the Black-Scholes option pricing model, deemed to be an appropriate model due to the terms of the Amended March 2025 Warrants issued, including a fixed term and exercise price.

The following table presents the Company’s transfers from Level 3 to Level 2 during the nine months ended September 30, 2025.

(Amounts in Thousands)

Balance as of January 1, 2025

Change in warrant value due to modification

Transfers out of Level 3

Balance as of September 30, 2025

Level 3 Warrant Liabilities

$

1,230

$

3,732

$

(4,962)

$

-

These transfers were primarily due to the change from the Monte Carlo simulation pricing model to the Black-Scholes option pricing model, deemed to be an appropriate model due to the terms of the Amended March 2025 Warrants issued, including a fixed term and exercise price. The fair value of the Amended March 2025 Warrants was affected by changes in inputs to the Black-Scholes option pricing model including the Company’s stock price, expected stock price volatility, the contractual term, and the risk-free interest rate. This model uses Level 2 inputs, including stock price volatility, in the fair value hierarchy established by ASC 820, Fair Value Measurement. The Amended March 2025 Warrants are classified in warrant liabilities on the Company’s unaudited condensed consolidated balance sheets.

The Company used the following key inputs to determine the fair value of the March 2025 Warrants. For September 30, 2025, the Company used the Black-Scholes option pricing model. For March 12, 2025, the Company used the Monte Carlo simulation pricing model.

    

September 30, 2025

    

March 12, 2025

 

Exercise price (first 24 months)

$

0.35

$

0.25

Exercise price

$

0.35

$

0.50

Volatility

 

128.6

%  

 

105.7

%

Risk-free interest rate

 

3.71

%  

 

4.03

%

Remaining term (years)

 

5.4

 

5.0

Weighted average fair value

$

0.44

$

0.12

The Company recorded the Convertible Notes on its books at fair value. The fair value of the Convertible Notes was calculated by backing out the fair value of the March 2025 Warrants, which was estimated using a Monte Carlo simulation pricing model. The Monte Carlo simulation pricing model uses Level 3 inputs due to its incorporation of significant inputs that are not observable in the market. The fair value of the convertible notes at issuance was approximately $2,563,000. Accordingly, on the date of issuance, the Company recorded a loss of $1,198,000, which is the difference between the fair value and the proceeds received. The Convertible Notes were marked to market through the date of conversion, March 12, 2025. The change in fair value from the date of issuance through the date of conversion was a gain of $170,000 which was recognized in Change in fair value of Convertible Notes in the accompanying condensed consolidated financial statements.

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The following is a reconciliation of the fair values from December 31, 2024 to September 30, 2025.

    

Fair Value of

    

Fair Value of

    

Total Fair Value

August 2022

March 2025

of Warrant

(in thousands)

Warrants

Warrants

Liability

August 2022 Warrant liability – December 31, 2024

$

60

$

-

$

60

Warrant liability – March 12, 2025

 

-

1,477

 

1,477

Change in fair value (loss) reported in statement of operations

6

4,006

4,012

Warrants exercised

 

-

 

(44)

 

(44)

Warrant liability – September 30, 2025

$

66

$

5,439

$

5,505

The carrying value of the Company’s insurance promissory note approximates fair value as of September 30, 2025 and December 31, 2024, due to the short-term nature of the insurance note and is classified as Level 2 within the fair value hierarchy.

The DECD loan is classified within Level 3 of the fair value hierarchy. The following table presents the carrying value and fair value of the DECD loan. The fair value of the DECD loan is estimated based on discounted cash flows using the prevailing market interest rates.

    

    

September 30, 

    

December 31, 

2025

2024

(in thousands)

 

Fair Value Hierarchy

 

Carrying Value

    

Fair Value

 

Carrying Value

    

Fair Value

DECD loan

 

Level 3

$

1,334

$

1,072

$

1,511

$

1,169

3. PREPAID AND OTHER CURRENT ASSETS

Prepaid and other current assets at September 30, 2025 and December 31, 2024 consist of the following:

    

September 30, 

    

December 31, 

(in thousands)

2025

2024

Prepaid insurance

$

63

$

629

Software licenses

 

77

 

90

Subscriptions

 

130

 

66

Other

 

147

 

313

Total prepaid and other current assets

$

417

$

1,098

4. INTANGIBLE ASSETS

During the nine months ended September 30, 2025, the Company purchased the capitalized software to provide integrated care plans for adnexal mass risk management. The Company classified the software as an Intangible asset.

Intangible assets as of September 30, 2025 and December 31, 2024 were as follows.

Estimated

September 30,

December 31,

(in thousands)

Useful Life

2025

2024

Capitalized software

3 years

385

-

Accumulated amortization

(42)

-

Capitalized software, net

$

343

$

-

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Amortization expense for Intangible assets was $42,000 and $0 for the three months ended September 30, 2025 and 2024, respectively. Amortization expense for Intangible assets was $42,000 and $0 for the nine months ended September 30, 2025 and 2024, respectively. Estimated future amortization is $32,000 for the remaining periods of 2025.

5. COMMITMENTS AND CONTINGENCIES, AND DEBT

Convertible Notes

On March 5, 2025, the Company entered into a securities purchase agreement with certain existing accredited shareholders (the “Purchasers”) for the issuance and sale in a private placement (the “March 2025 Private Placement”) of an aggregate gross principal amount of $1,365,500 in the form of Convertible Notes. The Company incurred third-party issuance costs of $50,000 in connection with the March 2025 Private Placement which were expensed within general and administrative expenses on its unaudited condensed consolidated statement of operations for the nine months ended September 30, 2025. The Convertible Notes were convertible into Units at a conversion price of $0.25 per Unit (the “Conversion Price”), with each Unit consisting of one share of common stock and 2.25 warrants to purchase shares of common stock.

The Company elected to measure the Convertible Notes using the fair value option under ASC 825 because the warrants issuable upon conversion of the Convertible Notes are not indexed to the Company’s stock. They included a variable exercise price that did not meet the fixed-for-fixed concept under ASC 815. Further, as the Convertible Notes were issued at par (gross cash proceeds equaled the principal of the Convertible Notes), the Convertible Notes were not issued at a substantial premium and were eligible for the fair value option under ASC 825.

The Convertible Notes were issued at a discount. This resulted in the fair value of the Convertible Notes upon issuance exceeding the proceeds received, As such, the Company recognized the excess of approximately $1,198,000 in Loss upon issuance of Convertible Notes carried at fair value on its unaudited condensed consolidated statement of operations during the nine months ended September 30, 2025. See Note 2, Fair Value Measurements, for the fair value disclosures related to the Convertible Notes.

The Purchasers of the Convertible Notes are entitled to three representatives on the Company’s board of directors.

In addition, the Company granted the Purchasers of the Convertible Notes certain customary registration rights with respect to the shares of common stock and shares of common stock underlying the March 2025 Warrants. The registration statement was filed on September 30, 2025.

Pursuant to the terms of the agreement, the Company exercised its option to convert the Convertible Notes into Units at the Conversion Price. The Convertible Notes, including interest accrued, for a total of $1,366,458 were converted into Units on March 12, 2025. A gain on the conversion of the Convertible Notes of $170,000 was recognized in Change in fair value of Convertible Notes on the Company’s unaudited condensed consolidated statement of operations for the nine months ended September 30, 2025. See Note 7, Stockholders’ Deficit, for further discussion on the warrants.

Loan Agreement

On March 22, 2016, the Company entered into a loan agreement (as amended, the “DECD Loan Agreement”) with the State of Connecticut Department of Economic and Community Development (the “DECD”), pursuant to which the Company may borrow up to $4,000,000 from the DECD. The loan bears interest at a fixed rate of 2.0% per annum and requires equal monthly payments of principal and interest until maturity, which occurs on January 1, 2032. As security for the loan, the Company has granted the DECD a blanket security interest in the Company’s personal and intellectual property. The DECD’s security interest in the Company’s intellectual property may be subordinated to a qualified institutional lender.

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The loan may be prepaid at any time without premium or penalty. An initial disbursement of $2,000,000 (“Loan 1”) was made to the Company on April 15, 2016 under the DECD Loan Agreement. On December 3, 2020, the Company received a disbursement of the remaining $2,000,000 (“Loan 2”) under the DECD Loan Agreement.

On June 26, 2023, the Company was notified by the DECD that the Company satisfied all job creation and retention requirements under the loan agreement to receive forgiveness of $1,000,000. If the Company fails to maintain its Connecticut operations through March 22, 2026, the DECD may require early repayment of a portion or all of the remaining amount of the loan plus a penalty of 5% of the total funded loan.

On June 6, 2023, the Company was granted a deferral of interest and principal payments on a portion of the remaining outstanding balances through December 1, 2023. On January 30, 2024, the Company was granted an additional deferral of interest and principal payments on a portion of the remaining outstanding balances through June 1, 2024. The Company determined the loan deferrals met the definition of a troubled debt restructuring under ASC 470-60, Troubled Debt Restructurings by Debtors, as the Company was experiencing financial difficulties, and the lenders granted a concession. The future undiscounted cash flows of the DECD loan after the loan deferrals exceeded the carrying value of the DECD loan prior to the loan deferrals. As such no gain was recognized as a result of the deferrals.

On October 2, 2024, the Company executed an additional deferral agreement (the “October 2 Deferral”), which provides for both the interest and principal payments on Loan 1 to be deferred for August and September 2024. Payments resumed in October 2024. The October 2 Deferral also provides for both the interest and principal payments on Loan 2 to be deferred from August 2024 to May 2027, with payments resuming in June 2027. The Company determined these loan deferrals also met the definition of a troubled debt restructuring under ASC 470-60, Troubled Debt Restructurings by Debtors, as the Company was experiencing financial difficulties, and the lenders granted a concession. The future undiscounted cash flows of the DECD loan after the loan deferrals exceeded the carrying value of the DECD loan prior to the loan deferrals. As such, no gain was recognized as a result of the deferrals. Long-term debt, as adjusted for the October 2 Deferral, consisted of the following:

    

September 30, 

    

December 31, 

(in thousands)

    

2025

    

2024

DECD loan, net of issuance costs

$

1,334

$

1,507

Less: Current portion, net of issuance costs

 

(234)

 

(229)

Total long-term debt, net of issuance costs

$

1,100

$

1,278

As of September 30, 2025, the annual amounts of future minimum principal payments due under the Company’s contractual obligation are shown in the table below. Unamortized debt issuance costs for the DECD loan were $2,000 and $4,000 as of September 30, 2025 and December 31, 2024, respectively.

Payments Due by Period

(in thousands)

    

Total

    

2025

    

2026

    

2027

    

2028

    

2029

    

Thereafter

DECD Loan

$

1,336

$

58

$

237

$

145

$

213

$

217

$

466

Total

$

1,336

$

58

$

237

$

145

$

213

$

217

$

466

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Insurance Notes

During 2024, the Company entered into an insurance promissory note for the payment of insurance premiums at an interest rate of 7.79%, with an aggregate principal amount outstanding of approximately $0 and $614,000 as of September 30, 2025 and December 31, 2024, respectively. Interest paid for the promissory note was $4,000 and $16,000 for the three and nine months ended September 30, 2025. Interest paid for the promissory note was $6,000 and $18,000 for the three and nine months ended September 30, 2024. The amount outstanding in 2025 could be substantially offset by the cancellation of the related insurance coverage which is classified in prepaid insurance. This note was payable in nine monthly installments with a maturity date of August 1, 2025 and had no financial or operational covenants.

Operating Leases

The Company leases facilities to support its business. The Company’s principal facility, including the Clinical Laboratory Improvements Amendments of 1988 (“CLIA”) laboratory used by Aspira Labs, Inc., is located in Austin, Texas, and an administrative office is also located in Shelton, Connecticut. The Company also had an administrative office in Palo Alto, California through May 31, 2024.

In December 2024, the Company extended the Austin, Texas lease for an additional 54 months. The lease renewal also expands the leased space. The Company’s renewed lease expires on August 31, 2031, with the option to extend the lease for an additional three years. Variable lease costs represent our share of the landlord’s operating expenses. The Company is not reasonably certain that it will exercise the three-year renewal option beginning on September 1, 2031.

On October 1, 2023, the Company began a five- year lease in Shelton, Connecticut. The Shelton, Connecticut lease extends through September 30, 2028. Continuation of the lease after the lease term would be on a month-to-month basis.

In January 2023, the Company entered into a new sublease agreement for an administrative facility in Palo Alto, California. The Company’s sublease term commenced in April 2023 and expired on May 31, 2024. The Company did not renew its lease with the sublessor. The sublessor, Invitae, filed for bankruptcy on February 15, 2024. The Company has applied for a refund of its approximately $10,000 security deposit with the bankruptcy court.

Effective October 31, 2023, the Company entered into a new lease agreement for freezer storage for its samples. The lease term is for 36 months with a twelve-month automatic renewal provision. The company leases 5 freezers at a total of $4,300 per month.

The expense associated with these operating leases for the three months ended September 30, 2025 and 2024 is shown in the table below (in thousands).

    

    

Three Months Ended

September 30, 

Lease Cost

Classification

2025

2024

Operating rent expense

 

  

 

  

 

  

 

Cost of revenue

$

19

$

19

 

Research and development

 

17

 

7

 

Sales and marketing

 

-

 

2

 

General and administrative

 

11

 

10

Variable rent expense

 

  

 

  

 

  

 

Cost of revenue

 

16

 

11

 

Research and development

 

14

 

4

 

Sales and marketing

 

-

 

2

 

General and administrative

 

11

 

8

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The expense associated with these operating leases for the nine months ended September 30, 2025 and 2024 is shown in the table below (in thousands).

    

    

Nine Months Ended September 30, 

Lease Cost

Classification

2025

2024

Operating rent expense

 

Cost of revenue

$

99

$

67

 

Research and development

 

47

 

38

 

Sales and marketing

 

2

 

5

 

General and administrative

 

34

 

52

Variable rent expense

 

  

 

  

 

  

 

Cost of revenue

$

45

$

33

 

Research and development

 

24

 

9

 

Sales and marketing

 

2

 

6

 

General and administrative

 

35

 

26

Based on the Company’s leases as of September 30, 2025, the table below sets forth the approximate future lease payments related to operating leases with initial terms of one year or more (in thousands).

Year

    

Payments

2025 (remaining three months)

$

80

2026

316

2027

 

283

2028

 

275

2029

 

230

Thereafter

 

397

Total Operating Lease Payments

 

1,581

Less: Imputed Interest

 

(286)

Present Value of Lease Liabilities

 

1,295

Less: Unamortized Tenant Improvement Allowance

 

(47)

Less: Operating Lease Liability, current portion

 

(187)

Operating Lease Liability, non-current portion

$

1,061

Weighted-average lease term and discount rate were as follows.

    

Nine Months Ended September 30, 

 

    

2025

    

2024

 

Cash paid for amounts included in measurement of lease liabilities:

Operating cash outflows relating to operating leases

$

265

$

257

Weighted-average remaining lease term (in years)

 

1.6

 

3.0

Weighted-average discount rate

 

7.63

%  

 

7.25

%

Non-cancellable Royalty Obligations

The Company is a party to an amended research collaboration agreement with The Johns Hopkins University School of Medicine under which the Company licenses certain of its intellectual property directed at the discovery and validation of biomarkers in human subjects, including but not limited to clinical application of biomarkers in the understanding, diagnosis and management of human disease. Under the terms of the amended research collaboration agreement, Aspira is required to pay the greater of 4% royalties on net sales of diagnostic tests using the assigned patents or annual minimum royalties of $57,500. Royalty expense for the three months ended September 30, 2025 and 2024 totaled $73,000 and $71,000, respectively, and are recorded in cost of revenue in the unaudited condensed consolidated statements of operations. Royalty expense for the nine months ended September 30, 2025 and 2024 totaled $219,000 and $222,000, respectively.

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Business Agreements

On August 8, 2022, the Company entered into a sponsored research agreement with Harvard’s Dana-Farber Cancer Institute, Brigham & Women’s Hospital, and Medical University of Lodz (the “Dana-Farber, Brigham, Lodz Research Agreement”), for the generation of a multi-omic, non-invasive diagnostic aid to identify endometriosis based on circulating microRNAs and proteins. The Dana-Farber, Brigham, Lodz Research Agreement requires payments to be made upon the achievement of certain milestones. Under the terms of and as further described in the Dana-Farber, Brigham, Lodz Research Agreement, payments of approximately $1,252,000 have or will become due from the Company to the counterparties upon successful completion of certain deliverables as follows: 68% was paid in 2022, 15% was paid in 2023, and the remaining 17% is payable as of September 30, 2025. During the three and nine months ended September 30, 2025, approximately $0 and $50,000 was recorded, respectively, as research and development expense in the unaudited condensed consolidated financial statement of operations for the project. During the three and nine months ended September 30, 2024, approximately $67,000 and $118,000 was recorded, respectively, as research and development expense in the unaudited condensed consolidated financial statement of operations for the project. From the inception of the Dana-Farber, Brigham, Lodz Research Agreement through September 30, 2025, research and development expenses in the cumulative amount of $1,252,000 have been recorded.

On March 20, 2023, the Company entered into a licensing agreement (“Dana-Farber, Brigham, Lodz License Agreement”) with Harvard’s Dana-Farber Cancer Institute, Brigham & Women’s Hospital, and Medical University of Lodz under which the Company will license certain of its intellectual property to be used in the Company’s OvaSuite product portfolio. Under the Dana-Farber, Brigham, Lodz License Agreement, the Company paid an initial license fee of $75,000 and pays an annual license maintenance fee of $50,000 on each anniversary of the date of the Dana-Farber, Brigham, Lodz License Agreement. Annual license maintenance fees totaled $13,000 for each of the three months ended September 30, 2025 and 2024, and are recorded in research and development costs on the Company’s unaudited condensed consolidated statements of operations. Annual license maintenance fees totaled $38,000 for each of the nine months ended September 30, 2025 and 2024.

The Dana-Farber, Brigham, Lodz License Agreement also requires non-refundable royalty payments of up to $1,350,000 based on certain regulatory approvals and commercialization milestones and further royalty payments based on the net sales of the Company’s products included under the Dana-Farber, Brigham, Lodz License Agreement. No milestones have been reached as of September 30, 2025.

Government Assistance

On October 23, 2024, the Advanced Research Projects Agency for Health (“ARPA-H”) announced that it had selected the Company as an awardee of the Sprint for Women’s Health. As an awardee, the Company would have received $10,000,000 in funding over two years through the Sprint for Women’s Health launchpad track for later-stage health solutions. The Company was entitled to payments based on the completion of certain agreed-upon milestones. The award also provided for access to advisors to support the successful completion and commercial launch of the test before the end of the two-year contract term.

The Company met the first milestone for payment in the fourth quarter of 2024 and received a payment of $2,000,000. The second milestone was met during the first quarter of 2025 and the Company received a payment of $1,500,000, which is recognized in Other expense (income), net in the unaudited condensed consolidated statement of operations for the nine months ended September 30, 2025.

On June 9, 2025, Aspira received notice from ARPA-H that ARPA-H and the assigned managing contractor, VentureWell, have determined that Aspira had not met the specifications of Milestone 3, and have therefore elected to terminate the contract award. The Company will continue to work on the design, development and commercial launch of this test.

On July 15, 2025, the Company received $1,013,000 in Employee Retention Tax Credits, which is recognized in Other expense (income), net in the unaudited condensed consolidated statement of operations for the nine months ended September 30, 2025.

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Contingent Liabilities

From time to time, the Company is involved in legal proceedings and regulatory proceedings arising from operations. The Company establishes reserves for specific liabilities in connection with legal actions that management deems to be probable and estimable. The Company is not currently a party to any proceeding, the adverse outcome of which would have a material adverse effect on the Company’s financial position or results of operations.

6. ACCRUED LIABILITIES

The following table describes the principal components of accrued liabilities on the Company’s unaudited condensed consolidated balance sheet as of September 30, 2025 and December 31, 2024.

September 30, 

December 31, 

(in thousands)

    

2025

    

2024

Payroll and benefits related expenses

$

1,025

$

1,448

Collaboration and research agreements expenses

 

184

 

228

Professional services

 

457

 

253

Other accrued liabilities

 

301

 

516

Total accrued liabilities

$

1,967

$

2,445

7. STOCKHOLDERS’ DEFICIT

2025 Private Placement Offering

On September 16, 2025, the Company entered into a securities purchase agreement with certain investors and board members in a private placement (the “2025 Private Placement Offering”). Pursuant to the 2025 Private Placement Offering, the Company issued an aggregate of 6,550,000 shares of its common stock and accompanying warrants (the “September 2025 Warrants”) to purchase an equal number of shares of common stock at a price of $0.45 per share and accompanying warrant. The September 2025 Warrants have an exercise price of $0.75 per share and are exercisable until their expiration on the fifth anniversary of the issuance date. The gross proceeds to the Company from the 2025 Private Placement Offering were approximately $2,949,000, before deducting issuance costs of approximately $134,000.

The Company evaluated the September 2025 Warrants and concluded that they met the criteria to be classified as equity within additional paid-in-capital.

2025 Equity Line of Credit Agreement

On April 4, 2025, the Company entered into an equity purchase agreement (the “2025 Equity Line of Credit Agreement”) with Triton Funds L.P. (“Triton”) for the purchase of up to $2.0 million of the Company’s shares of common stock.

Pursuant to the 2025 Equity Line of Credit Agreement, the Company issued 354,988 shares of restricted common stock to Triton for $25,000 and upon effectiveness of a registration statement registering the shares of Common Stock, the Company will be able to close on the sale of up to $2 million of Common Stock. The purchase price of the Common Stock is 75% of the lowest traded price of the Common Stock five (5) business days prior to a closing. Transaction costs of approximately $214,000 related to the execution of the 2025 Equity Line of Credit Agreement were incurred, all of which are recognized in Other expense (income), net in the unaudited condensed consolidated financial statements.

The 2025 Equity Line of Credit expired on September 30, 2025. The Company opted not to renew the upon its expiration on September 30, 2025.

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March 2025 Convertible Notes Settlement

On March 12, 2025, the Company issued warrants (the “March 2025 Warrants”) upon the conversion of the Convertible Notes (see Note 5, Commitments and Contingencies, and Debt). The March 2025 Warrants were exercisable for five years at $0.25 per share for the first 24 months after issuance, and $0.50 per share thereafter. In September 2025, the March 2025 Warrants were modified to a single exercise price of $0.35 per share and the termination date was extended to March 5, 2031.

The March 2025 Warrants are classified in warrant liabilities on the Company’s unaudited condensed consolidated balance sheets. The March 2025 Warrants are classified as liabilities because the settlement amount is not indexed to the Company’s stock as required by ASC 815, Derivatives and Hedging.

2024 Private Placement Offering

On July 1, 2024, the Company entered into a securities purchase agreement with certain investors in a private placement (the “2024 Private Placement Offering”). Pursuant to the 2024 Private Placement Offering, the Company issued an aggregate of 1,248,527 shares of its common stock and accompanying warrants (the “July 2024 Purchase Warrants”) to purchase an equal number of shares of common stock at a price of $1.53 per share and accompanying warrant. The July 2024 Purchase Warrants have an exercise price of $2.25 per share and are exercisable until their expiration on the third anniversary of the issuance date. The gross proceeds to the Company from the 2024 Private Placement Offering were approximately $1,909,000, before deducting issuance costs of approximately $72,000.

The Company evaluated the July 2024 Purchase Warrants and concluded that they met the criteria to be classified as equity within additional paid-in-capital.

In February 2025, the Company modified 27,778 of the July 2024 Purchase Warrants to require shareholder approval of the July 2024 Purchase Warrants prior to their becoming exercisable. The Company evaluated the impact of the modification and it was not material to the unaudited condensed consolidated financial statements.

2024 At the Market Offering

On August 2, 2024, the Company entered into an At the Market offering agreement (the “2024 At the Market Offering”) with H.C. Wainwright to sell shares of its common stock, having an aggregate sales price of up to $4,450,000, from time to time, through an “at the market offering” program under which H.C. Wainwright acts as sales agent. The Company pays Wainwright a commission rate equal to 3.0% of the aggregate gross proceeds from each sale of shares under the 2024 At the Market Offering. The Company also reimbursed H.C. Wainwright for certain specified expenses in connection with entering into the 2024 At the Market Offering.

During the year ended December 31, 2024, the Company sold 1,073,050 shares under the 2024 At the Market Offering for gross proceeds of approximately $903,000. The Company incurred approximately $240,000 of costs related to the execution of the 2024 At the Market Offering, all of which were recorded as an offset to additional paid-in capital on the Company’s balance sheet as of December 31, 2024.

During the nine months ended September 30, 2025, the Company sold 12,277,441 shares under the 2024 At the Market Offering Agreement for gross proceeds of approximately $3,484,000 before deducting expenses of approximately $147,000. The total gross proceeds to the Company over the life of the At the Market Offering Agreement is $4,388,000 and the value of the remaining availability was approximately $62,000 that could be sold to H.C. Wainwright under the 2024 At the Market Offering Agreement, subject to the terms of the 2024 At the Market Offering Agreement.

2024 Securities Purchase Agreements

In August 2024, the Company entered into securities purchase agreements with two shareholders under which it sold a total of 9,733 shares of common stock and received proceeds of approximately $11,000.

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2024 Warrant Inducement Agreement

On July 31, 2024, the Company entered into a warrant inducement agreement (the “Warrant Inducement Agreement”) with a certain holder (the “Holder”) of (i) warrants to purchase 311,111 shares of common stock dated August 22, 2022 (the “August 2022 Warrants”) and (ii) warrants to purchase 1,400,000 shares of common stock dated January 26, 2024 (the “January 2024 Warrants”), pursuant to which the Holder agreed to exercise in cash the warrants held at a reduced exercise price of $1.25 per share (reduced from $4.13 per share for the August 2022 Warrants and $4.13 for the January 2024 Warrants).

As an inducement to such exercise, the Company agreed to issue to the Holder new common stock warrants (collectively, the “August 2024 Purchase Warrants”), to purchase up to 2,566,667 shares of common stock. The August 2024 Purchase Warrants were exercisable immediately after issuance and will expire 5 years from the initial exercise date.

The transaction, which closed on August 1, 2024, resulted in net proceeds of approximately $1,862,000. The Warrant Inducement Agreement was executed to encourage the exercise of the August 2022 Warrants and January 2024 Purchase Warrants to obtain capital for operations. The $1,323,000 incremental value transferred for the modification to both the August 2022 Warrants and January 2024 Purchase Warrants as a result of the Warrant Inducement Amendment was accounted for as an equity issuance cost and recognized within additional paid in capital in the audited consolidated balance sheets.

The Company evaluated the August 2024 Purchase Warrants and concluded that they met the criteria to be classified as equity within additional paid-in-capital.

2024 Registered Direct Offering

On January 24, 2024, the Company entered into a securities purchase agreement (the “2024 Direct Offering Agreement”), with several investors relating to the issuance and sale of 1,371,000 shares of its common stock, par value $0.001 per share, and pre-funded warrants to purchase 200,000 shares of common stock (the “Pre-Funded Warrants”), in a registered direct offering, together with accompanying warrants to purchase 1,571,000 shares of common stock (the “Purchase Warrants”, and together with the Pre-Funded Warrants, the “2024 Warrants”) in a concurrent private placement (the “Concurrent Private Offering” and together with the registered direct offering, the “2024 Direct Offering”).

Pursuant to the 2024 Direct Offering Agreement, the Company issued 1,368,600 shares of common stock to certain investors at an offering price of $3.50 per share, and 2,400 shares of common stock to its Chief Executive Officer, Nicole Sandford, at an offering price of $4.255 per share, which was the consolidated closing bid price of the Company’s common stock on The Nasdaq Capital Market on January 24, 2024 of $4.13 per share plus $0.125 per Purchase Warrant. The purchase price of each Pre-Funded Warrant is equal to the combined purchase price at which a share of common stock and the accompanying Purchase Warrant is sold in this 2024 Direct Offering, minus $0.0001. The gross proceeds to the Company from the 2024 Direct Offering were approximately $5,563,000, before deducting placement agent fees and other expenses of approximately $733,000 payable by the Company. The 2024 Direct Offering closed on January 26, 2024.

The Pre-Funded Warrants were exercisable at any time after the date of issuance and had an exercise price of $0.0001 per share. A holder of Pre-Funded Warrants could not exercise the warrant if the holder, together with its affiliates, would beneficially own more than 9.99% of the number of shares of common stock outstanding immediately after giving effect to such exercise. A holder of Pre-Funded Warrants may increase or decrease this percentage to a percentage not in excess of 9.99% by providing at least 61 days’ prior notice to the Company. All of the Pre-Funded Warrants were exercised on February 6, 2024 for gross proceeds of $20.

The Purchase Warrants have an exercise price of $4.13 per share and were exercisable beginning six months after issuance and will expire 5 years from the initial exercise date. 1,400,000 of the Purchase Warrants were exercised on August 1, 2024 under the Warrant Inducement Agreement at a reduced price of $1.25 per share.

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The Company engaged AGP to act as sole placement agent in the 2024 Direct Offering. The Company paid the placement agent a cash fee equal to 7.0% of the aggregate gross proceeds generated from the 2024 Direct Offering, except that, with respect to proceeds raised in this 2024 Direct Offering from certain designated persons, AGP’s cash fee was reduced to 3.5% of such proceeds, and to reimburse certain fees and expenses of the placement agent in connection with the 2024 Direct Offering. The Company also reimbursed the placement agent for its accountable offering-related legal expenses of $75,000 and a non-accountable expense allowance of $30,000. Costs related to the 2024 Direct Offering were recorded as an offset to additional paid-in capital on the Company’s balance sheet as of December 31, 2024.

The Company evaluated the Pre-Funded Warrants and the Purchase Warrants and concluded that they met the criteria to be classified as equity within additional paid-in-capital.

2023 Equity Line of Credit

On March 28, 2023, the Company entered into a purchase agreement (the “2023 Equity Line of Credit Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”) and a registration rights agreement (the “LPC Registration Rights Agreement”), pursuant to which the Company has the right, in its sole discretion, to sell to Lincoln Park shares of the Company’s common stock, par value $0.001 per share, having an aggregate value of up to $10,000,000 (the “Purchase Shares”), subject to certain limitations and conditions set forth in the 2023 Equity Line of Credit Agreement.

The issuance of the Purchase Shares had been previously registered pursuant to the Company’s effective shelf registration statement on Form S-3 (File No. 333-252267) (the “Old Registration Statement”), and the related base prospectus included in the Registration Statement, as supplemented by a prospectus supplement filed on March 28, 2023, that has expired. On April 22, 2024, the Company filed a registration statement on Form S-3 (File No. 333-278867) (the “Registration Statement”), and the related base prospectus included in the Registration Statement, that was declared effective by the SEC on April 25, 2024.

During the year ended December 31, 2024, the Company sold 949,574 shares under the 2023 Equity Line of Credit Agreement for gross proceeds of approximately $1,900,000. There were no shares sold in the first quarter of 2025. Over the life of the 2023 Equity Line of Credit Agreement through December 31, 2024, the Company sold 1,310,517 shares for gross proceeds of approximately $3,078,000. The Company incurred approximately $326,000 of costs related to the execution of the 2023 Equity Line of Credit Agreement, all of which are reflected in the unaudited condensed consolidated financial statements. The Company incurred approximately $0 and $249,000 for legal fees during the nine months ended September 30, 2025 and 2024, respectively, and included the costs in general and administrative expenses on its statement of operations. As of November 8, 2025, the remaining availability under the 2023 Equity Line of Credit Agreement was $1,700,000 of shares of common stock that could be sold to Lincoln Park under the 2023 Equity Line of Credit Agreement, subject to the terms of the 2023 Equity Line of Credit Agreement.

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Warrants

The following table is a summary of the Company’s warrants outstanding and exercisable as of September 30, 2025.

Number of Warrants

Exercise

Outstanding and Common

Price

Stock Underlying Warrants

    

Issuance Date

    

Expiration Date

    

Classification

per Share

    

September 30, 2025

    

December 31, 2024

Unmodified August 2022 Warrants

August 25, 2022

August 25, 2027

Liability

$

13.20

433,321

433,321

Modified August 2022 Warrants

August 25, 2022

August 25, 2027

Liability

$

4.13

55,553

55,553

January 2024 Purchase Warrants

January 26, 2024

July 26, 2029

Equity

$

4.13

171,000

171,000

July 2024 Purchase Warrants

July 9, 2024

July 9, 2027

Equity

$

2.25

1,248,527

1,248,527

August 2024 Purchase Warrants

August 1, 2024

August 1, 2029

Equity

$

1.36

2,566,667

2,566,667

Amended March 2025 Warrants

September 19, 2025

March 5, 2031

Liability

$

0.35

11,848,177

 

-

September 2025 Purchase Warrants

September 19, 2025

September 19, 2031

Equity

$

0.75

4,912,500

-

 

21,235,745

4,475,068

2010 Stock Incentive Plan

The Company’s employees, directors, and consultants were eligible to receive awards under the Vermillion, Inc. Second Amended and Restated 2010 Stock Incentive Plan (the “2010 Plan”), which was replaced by the 2019 Plan (as defined below) with respect to future equity grants. As of September 30, 2025, there were no shares of the Company’s common stock available for future grants under the 2010 Plan.

There was no stock option activity for the 2010 Plan during the three and nine months ended September 30, 2025.

As of September 30, 2025, there were 14,108 outstanding options under the 2010 Plan with the weighted average exercise price of $19.86 and the weighted average remaining life of 2.37 years. There were no unvested outstanding options under the 2010 Plan.

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2019 Stock Incentive Plan

At the Company’s 2019 annual meeting of stockholders, the Company’s stockholders approved the Vermillion, Inc. 2019 Stock Incentive Plan, the name of which was subsequently changed to the Aspira Women’s Health Inc. 2019 Stock Incentive Plan (the “2019 Plan”). The purposes of the 2019 Plan are (i) to align the interests of the Company’s stockholders and recipients of awards under the 2019 Plan by increasing the proprietary interest of such recipients in the Company’s growth and success; (ii) to advance the interests of the Company by attracting and retaining non-employee directors, officers, other employees, consultants, independent contractors and agents; and (iii) to motivate such persons to act in the long-term best interests of the Company and its stockholders. The 2019 Plan allows the Company to grant stock options, stock appreciation rights, restricted stock, restricted stock units and performance awards to participants.

Subject to the terms and conditions of the 2019 Plan, the initial number of shares authorized for grants under the 2019 Plan was 699,485. With shareholder approval, the total number of shares available to be issued as of September 30, 2025 has been increased to 4,532,818 shares. To the extent an equity award granted under the 2019 Plan expires or otherwise terminates without having been exercised or paid in full, or is settled in cash, the shares of common stock subject to such award will become available for future grant under the 2019 Plan. As of September 30, 2025, 1,837,937 shares of Aspira common stock were subject to outstanding stock options, and no shares of Aspira common stock were subject to unreleased restricted stock awards. A total of 2,052,560 shares of Aspira common stock were reserved for future issuance under the 2019 Plan.

The following table summarizes stock option activity for the 2019 Plan during the nine months ended September 30, 2025.

Options outstanding at December 31, 2024

 

861,342

Options granted

 

1,623,400

Options forfeited or expired

 

(646,805)

Options outstanding at September 30, 2025

 

1,837,937

Vested and Exercisable options at September 30, 2025

 

192,359

As of September 30, 2025, the weighted average exercise price of outstanding options under the 2019 Plan was $1.05 and the weighted average remaining life was 9.61 years. As of September 30, 2025, the weighted average exercise price of vested and exercisable options under the 2019 Plan was $6.94 and the weighted average remaining life was 8.35 years.

The following table summarizes RSU activity for the 2019 Plan during the nine months ended September 30, 2025.

RSUs outstanding at December 31, 2024

 

149,061

RSUs granted

 

6,458

RSUs vested and issued

 

(150,519)

RSUs forfeited or expired

 

(5,000)

RSUs outstanding at September 30, 2025

-

Stock-Based Compensation

During the nine months ended September 30, 2025, the Company granted option awards under the 2019 Plan with a weighted average grant date fair value of $0.16 and a weighted average exercise price of $0.21.

Assumptions included in the fair value per share calculations were (i) expected terms of two to three years, (ii) two- to three-year treasury interest rates of 3.63% to 4.25% and (iii) market close prices ranging from $0.72 to $0.07. The Company recorded $77,000 in forfeitures for the nine months ended September  30, 2025.

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The allocation of non-cash stock-based compensation expense by functional area for the three and nine months ended September 30, 2025 and 2024 was as follows.

    

Three Months Ended

    

Nine Months Ended

September 30, 

September 30, 

(in thousands)

2025

    

2024

2025

    

2024

Cost of revenue

$

3

$

6

$

12

$

32

Research and development

 

10

 

46

 

11

 

136

Sales and marketing

 

12

 

95

 

30

 

139

General and administrative

 

12

 

232

 

102

 

556

Total

$

37

$

379

$

155

$

863

As of September 30, 2025, total unrecognized compensation cost related to unvested stock option awards was approximately $181,000, and the related weighted average period over which it is expected to be recognized was 1.97 years. There were no unrecognized compensation costs related to restricted stock units as of September 30, 2025.

8. LOSS PER SHARE

The Company calculates basic loss per share using the weighted average number of shares of Aspira common stock outstanding during the period. The Company considers the 2022 Warrants and the March 2025 Warrants, and during the period outstanding, the Convertible Notes (see Note 5, Commitments and Contingencies, and Debt) to be participating securities, because holders of such instruments participate in the event a dividend is paid on common stock. The holders of the 2022 Warrants and the March 2025 Warrants and the Convertible Notes do not have a contractual obligation to share in the Company’s losses. As such, losses are attributed entirely to common stockholders and for periods in which the Company has reported a net loss, diluted loss per common share is the same as basic loss per common share.

Three Months Ended

Nine Months Ended

September 30, 

September 30, 

2025

    

2024

2025

    

2024

Numerator:

 

  

 

  

 

  

 

  

Net Loss

$

(4,892)

$

(3,547)

$

(9,411)

$

(11,706)

Denominator:

 

  

 

  

 

  

 

  

Shares used in computing net loss per share, basic and diluted

 

36,388,370

 

15,405,672

 

31,203,821

 

13,269,646

Net loss per share, basic and diluted

$

(0.13)

$

(0.23)

$

(0.30)

$

(0.88)

The dilutive potential shares of common stock are computed using the treasury stock method or the as-if converted method, as applicable. Because the Company is in a net loss position, diluted loss per share is calculated using the weighted average number of common shares outstanding and excludes the effects of potential shares of common stock that are antidilutive.

The potential shares of common stock that have been excluded from the diluted loss per share calculation above for the three and nine months ended September 30, 2025 and 2024 were as follows:

    

Three and Nine Months Ended September 30, 

2025

    

2024

Stock options

 

1,852,045

 

839,450

Restricted stock units

 

-

 

153,750

Warrants

 

21,235,745

 

4,475,068

Potential common shares

 

23,087,790

 

5,468,268

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The Company considered the Convertible Notes to be participating securities, because holders of such instruments participate in the event a dividend is paid on common stock. The holders of the Convertible Notes did not have a contractual obligation to share in the Company’s losses. As such, losses were attributed entirely to common stockholders.

9: RELATED PARTY TRANSACTIONS

On December 1, 2023, the Company entered into a consulting agreement with Biodesix, Inc. (the “Biodesix Agreement”) to assist with our miRNA product pipeline. Jack Schuler, a beneficial owner of more than 5% of the Company’s stock, is also a beneficial owner of more than 10% of the stock of Biodesix, Inc. Since the inception of the Biodesix Agreement, the Company has recorded $125,000 in costs under the Biodesix Agreement as research and development expense in our consolidated financial statement of operations. As of September 30, 2025, the Company had no current liabilities recorded on its unaudited condensed consolidated balance sheet for Biodesix.

On March 5, 2025, the Company entered into the March 2025 Private Placement with the Purchasers for the issuance and sale of Convertible Notes. The Convertible Notes, including interest accrued, were converted into units consisting of one share of common stock and 2.25 warrants on March 12, 2025.

The Purchasers are entitled to nominate three representatives on the Company’s board of directors until the earlier of (i) both (a) three (3) years from the date of the Amendment and (b) one (1) year after the common stock of the Company has been listed on a national securities exchange, or (ii) the date on which the Purchasers, on an aggregate basis, hold less than fifty percent (50%) of the Amended March 2025 Warrants. Two of the of the three bord members have been appointed. On April 2, 2025, the Board of Directors (the “Board”) of the Company appointed Jeffrey Cohen, M.D. as a director of the Company. The Board appointed John Fraser as Director of the Company on April 6, 2025.

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ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Forward-Looking Statements

This Quarterly Report on Form 10-Q contains forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995.

These statements involve a number of risks and uncertainties. Words such as “may,” “expects,” “intends,” “anticipates,” “believes,” “estimates,” “plans,” “seeks,” “could,” “should,” “continue,” “will,” “potential,” “targeted,” “projects,” “aim” and similar expressions are intended to identify such forward-looking statements. Readers are cautioned that these forward-looking statements speak only as of the date on which this Quarterly Report on Form 10-Q is filed with the Securities and Exchange Commission (the “SEC”), and, except as required by law, Aspira Women’s Health Inc. (“Aspira” and, together with its subsidiaries, the “Company,” “we,” “our,” or “us”) does not assume any obligation to update, amend or clarify them to reflect events, new information or circumstances occurring after such date.

Examples of forward-looking statements include, without limitation:

projections or expectations regarding our future test volumes, revenue, average unit price, cost of revenue, operating expenses, research and development expenses, gross profit margin, cash flow, results of operations and financial condition;
our plan to broaden our commercial focus from ovarian cancer to differential diagnosis of women with a range of gynecological diseases, including additional pelvic disease conditions such as endometriosis and benign pelvic mass monitoring;
our planned business strategy and the anticipated effects thereof, including partnerships such as those based on our Aspira Synergy platform, specimen or research collaborations, licensing arrangements, commercial collaborations and distribution agreements;
plans to expand our current or future products to markets outside of the United States through distribution collaborations or out-licensing;
plans to develop new algorithms, molecular diagnostic tests, products and tools and otherwise expand our product offerings;
plans to develop, launch and establish payer coverage and secure contracts for current and new products, including ENDOinform and OVAinform;
expectations regarding local and/or national coverage under Novitas, our Medicare Administrative Carrier;
anticipated efficacy of our products, product development activities and product innovations, including our ability to improve sensitivity and specificity over traditional diagnostics;
expected competition in the markets in which we operate;
plans with respect to Aspira Labs, Inc. (“Aspira Labs”), including plans to expand Aspira Labs’ testing capabilities, specifically molecular lab capabilities;
expectations regarding continuing future services provided by Quest Diagnostics Incorporated;
expectations regarding continuing future services provided by BioReference Health, LLC;

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plans to develop informatics products as laboratory developed tests (“LDTs”) and potential Food and Drug Administration (“FDA”) oversight changes of LDTs;
expectations regarding existing and future collaborations and partnerships for our products, including plans to enter into decentralized arrangements for our Aspira Synergy platform and to provide and expand access to our risk assessment tests;
plans regarding future publications and presentations;
expectations regarding potential collaborations with governments, legislative bodies and advocacy groups to enhance awareness and drive policies to provide broader access to our tests;
our ability to continue to comply with applicable governmental regulations, including regulations applicable to the operation of our clinical lab, expectations regarding pending regulatory submissions and plans to seek regulatory approvals for our tests within the United States and internationally, as applicable;
our continued ability to expand and protect our intellectual property portfolio;
anticipated liquidity and capital requirements;
anticipated future losses and our ability to continue as a going concern;
expectations regarding raising capital and the amount of financing anticipated to be required to fund our planned operations;
expectations regarding attrition and recruitment of top talent;
expectations regarding the results of our clinical research studies and our ability to recruit patients to participate in such studies;
our ability to use our net operating loss carryforwards and anticipated future tax liability under U.S. federal and state income tax legislation;
expected market adoption of our current and prospective diagnostic tests, including Ova1, Overa, Ova1Plus, OvaWatch, ENDOinform and OVAinform, as well as our Aspira Synergy platform;
expectations regarding our ability to launch new products we develop, license, co-market or acquire;
expectations regarding the size of the markets for our products;
expectations regarding reimbursement for our products, and our ability to obtain such reimbursement, from third-party payers such as private insurance companies and government insurance plans;
potential plans to pursue clearance designation with the FDA with respect to OvaWatch, ENDOinform and OVAinform;
expected potential target launch timing for future products;
expectations regarding compliance with federal and state laws and regulations relating to billing arrangements conducted in coordination with laboratories;
plans to advocate for legislation and professional society guidelines to broaden access to our products and services;

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ability to protect and safeguard against cybersecurity risks and breaches; and
expectations regarding the results of our academic research agreements.

We caution you that the foregoing list may not contain all of the forward-looking statements made in this Quarterly Report on Form 10-Q.

Forward-looking statements are subject to significant risks and uncertainties, including those discussed in Part I Item 1A, “Risk Factors,” of our Annual Report on Form 10-K for the year ended December 31, 2024, as filed on March 27, 2025, as supplemented by the section titled “Risk Factors” in this Quarterly Report on Form 10-Q, that could cause actual results to differ materially from those projected in such forward-looking statements due to various factors, including our ability to continue as a going concern; impacts resulting from potential changes to coverage of Ova1 through our Medicare Administrative Carrier for Ova1; anticipated use of capital and its effects; our ability to increase the volume of our product sales; failures by third-party payers to reimburse for our products and services or changes to reimbursement rates; our ability to continue developing existing technologies and to develop, protect and promote our proprietary technologies; plans to develop and perform LDTs; our ability to comply with FDA regulations that relate to our products and to obtain any FDA clearance or approval required to develop and commercialize medical devices; our ability to develop and commercialize additional diagnostic products and achieve market acceptance with respect to these products; our ability to compete successfully; our ability to obtain any regulatory approval required for our future diagnostic products; our or our suppliers’ ability to comply with FDA requirements for production, marketing and post-market monitoring of our products; our ability to maintain sufficient or acceptable supplies of immunoassay kits from our suppliers; in the event that we succeed in commercializing our products outside the United States, the political, economic and other conditions affecting other countries; changes in healthcare policy; our ability to comply with environmental laws; our ability to comply with the additional laws and regulations that apply to us in connection with the operation of Aspira Labs; our ability to use our net operating loss carryforwards; our ability to use intellectual property; our ability to successfully defend our proprietary technology against third parties; our ability to obtain licenses in the event a third party successfully asserts proprietary rights; the liquidity and trading volume of our common stock; the concentration of ownership of our common stock; our ability to retain key employees; our ability to secure additional capital on acceptable terms to execute our business plan; business interruptions or force majeure or acts of God; the effectiveness and availability of our information systems; our ability to integrate and achieve anticipated results from any acquisitions or strategic alliances; future litigation against us, including infringement of intellectual property and product liability exposure; and additional costs that may be required to make further improvements to our laboratory operations.

Other sections of this Quarterly Report on Form 10-Q may include additional factors that could harm our business and financial performance. Moreover, we operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time, and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ from those contained in, or implied by, any forward-looking statements.

Company Overview

Corporate Vision

We are dedicated to the discovery, development, and commercialization of noninvasive, AI-powered tests to aid in the diagnosis of gynecologic diseases, starting with ovarian cancer.

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We plan to broaden our focus to the differential diagnosis of other gynecologic diseases that typically cannot be assessed through traditional non-invasive clinical procedures. We expect to continue commercializing our existing and new technology through both in-house and distributed pathways. We also intend to continue to raise public awareness regarding the diagnostic superiority of Ova1Plus as compared to cancer antigen 125 (“CA-125”) on its own for all women with adnexal masses, as well as the superior performance of our tests in detecting ovarian cancer in different racial populations. We plan to continue to expand access to our tests among Medicaid patients as part of our corporate mission to make the best care available to all women, and we plan to advocate for legislation and the adoption of our technology in professional society guidelines to provide broad access to our products and services.

We expect our extensive experience with gynecologists and healthcare providers, along with the historical adoption of our OvaSuite tests, to continue to drive growth as we introduce new products. We believe our ability to successfully develop novel AI-enabled assays is superior to others based on our know-how and extensive experience in designing and successfully launching FDA-approved and laboratory developed blood tests to aid in the diagnosis of ovarian cancer. Moreover, our history of successfully collaborating with world-class research and academic institutions allows us to innovate and provide outstanding patient care.

We own and operate Aspira Labs, Inc., a research and commercial CLIA laboratory in Texas.

Our product pipeline is focused on two areas: endometriosis and ovarian cancer.

In endometriosis, we are developing and intend to introduce a new non-invasive test to aid in the diagnosis of this debilitating disease that impacts millions of women worldwide. Our ENDOinform program focused on developing a multi-marker test that combines serum proteins, clinical data (metadata) and miRNA for the identification of endometriosis.

Our endometriosis portfolio addresses an even larger addressable market. According to the U.S. Department of Health and Human Services, endometriosis affects more than 6.5 million women in the United States. We believe the proliferation of commercially available and in-development therapeutics for the treatment of endometriosis will create a significant demand for a non-invasive diagnostic.

In ovarian cancer, we have developed clinical data to support the use of our OvaWatch test multiple times for the monitoring of an adnexal mass. In the second quarter of 2024, we expanded the features of our commercially available OvaWatch test for monitoring of adnexal masses through periodic testing at physician prescribed intervals, marking the successful completion of the vision for OvaSuite. The successful expansion of the OvaWatch mass monitoring feature in the second quarter of 2024 resulted in a tenfold increase in the market for our tests when compared to the addressable market for Ova1Plus of approximately 200,000 to 400,000 based on patients identified for surgery. As a result, we believe the addressable market for our tests to have increased to between 2 and 4 million tests per year.

Our OVAinform development program continues to progress. OVAinform is a multi-marker test that combines serum proteins, clinical data (metadata), and miRNA for assessing the risk of ovarian cancer. We believe there is utility in expanding the OVAinform indication to include asymptomatic women at elevated risk due to genetic risk or first degree relatives with ovarian cancer. The inclusion of this cohort in our indication will increase the addressable market to 2.8 million women.

Our Business and Products

We currently commercialize the following products and related services:

(1)the Ova1Plus workflow, which uses Ova1 as the primary test and Overa as a reflex for Ova1 intermediate range results. Ova1 is a qualitative serum test intended as an aid to further assess the likelihood of malignancy in women with an ovarian adnexal mass for which surgery is planned when the physician’s independent clinical and radiological evaluation does not indicate malignancy. Overa is a second-generation biomarker test intended to maintain Ova1’s high sensitivity while improving specificity. The Ova1Plus workflow leverages the strengths of Ova1’s MIA sensitivity and Overa’s (MIA2G) specificity to increase performance; and

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(2)OvaWatch, which is intended to assist in the initial and periodic clinical assessment of malignancy risk in all women thought to have an indeterminate or benign adnexal mass.

Our products are distributed through our direct national sales force, including field sales and inside sales. OvaSuite tests are marketed to both physicians via a direct referral to Aspira as well as to laboratires via our Aspira Synergy platform. We also engage in channel distribution partnerships by which OvaSuite is distributed via laboratory partners such as BioReference Health, LLC. (“BioReference”) and ARUP Laboratories. In November of 2024, we expanded our distribution agreement with BioReference to include OvaWatch. This timing aligns with our approval from New York State to sell OvaWatch and increases our ability to market the test in New York. This important addition allows providers who currently order Ova1 through BioReference to also order Aspira’s products for any woman with a mass within their existing BioReference workflows.

Our Ova1 test received FDA de novo classification in September 2009. Ova1 comprises instruments, assays, reagents, and the OvaCalc software, which includes a proprietary algorithm that produces a risk score. Our Overa test, which includes an updated version of OvaCalc, received FDA 510(k) clearance in March 2016. Ova1, Overa and OvaWatch each use the Roche Cobas 4000, 6000 and 8000 platforms for analysis of proteins. Revenue from these sources is included in the results of operations in total revenue for the three and nine months ended September  30, 2025.

OvaWatch has been developed and is validated for use in Aspira’s CLIA-certified lab as a non-invasive blood-based risk assessment test for use in conjunction with clinical assessment and imaging to determine ovarian cancer risk for patients with an adnexal mass whose adnexal mass has been determined by an initial clinical assessment as indeterminate or benign. The commercialization plan for OvaWatch has two phases. Phase I, which was launched during the fourth quarter of 2022, is a single use, point-in-time risk assessment test, and Phase II, which was launched during the second quarter of 2024 allows for longitudinal testing. We believe OvaWatch has the potential to significantly expand the addressable market compared to the Ova1Plus workflow.

We own and operate Aspira Labs, based in Austin, Texas, a Clinical Chemistry and Endocrinology Laboratory accredited by the College of American Pathologists, which specializes in applying biomarker-based technologies to address critical needs in the management of gynecologic cancers and disease. Aspira Labs provides expert diagnostic services using a state-of-the-art biomarker-based risk assessment to aid in clinical decision making and to advance personalized treatment plans. The lab currently performs our Ova1Plus workflow and OvaWatch testing, and we plan to expand the testing to other gynecologic conditions with high unmet needs. Aspira Labs holds a CLIA Certificate of Accreditation and a state laboratory license in California, Maryland, New York, Pennsylvania and Rhode Island. The Centers for Medicare & Medicaid Services (“CMS”) issued a supplier number to Aspira Labs in 2015. Aspira Labs also holds a current ISO 13485 certification which is the most accepted standard worldwide for medical devices.

In the United States, revenue for diagnostic tests comes from several sources, including third-party payers such as insurance companies, government healthcare programs, such as Medicare and Medicaid, client bill accounts and patients. Novitas Solutions, a Medicare Administrative Carrier, covers and reimburses for Ova1 tests performed in certain states, including Texas. Due to our billed Ova1 tests being performed exclusively at Aspira Labs in Texas, the Local Coverage Determination (“LCD”) from Novitas Solutions essentially provides national coverage for patients enrolled in Medicare as well as Medicare Advantage health plans. We have applied for an LCD for OvaWatch, which is currently under review.

In November 2016, the American College of Obstetricians and Gynecologists (“ACOG”) issued Practice Bulletin Number 174 which included Ova1, defined as the “Multivariate Index Assay,” outlining ACOG’s clinical management guidelines for adnexal mass management. Practice Bulletin Number 174 recommends that obstetricians and gynecologists evaluating women with adnexal masses who do not meet Level A criteria of a low-risk transvaginal ultrasound should proceed with Level B clinical guidelines. Level B guidelines state that the physician may use risk-assessment tools such as existing CA-125 technology or Ova1 (“Multivariate Index Assay”) as listed in the bulletin. Based on this, Ova1 achieved parity with CA-125 as a Level B clinical recommendation for the management of adnexal masses.

Practice Bulletins summarize current information on techniques and clinical management issues for the practice of obstetrics and gynecology. Practice Bulletins are evidence-based documents, and recommendations are based on the

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evidence. This is also the only clinical management tool used for adnexal masses. Although there are Practice Bulletins, guidelines do not exist for adnexal masses. ACOG guidelines do exist, however, for ovarian cancer management.

Product Pipeline

We aim to introduce new gynecologic diagnostic products and to expand our product offerings to additional women’s gynecologic health diseases by adding additional gynecologic bio-analytic solutions involving biomarkers, genetics, clinical risk factors and patient data to aid diagnosis and risk stratification. Future product expansions will be accelerated by the development of lab developed testing in a CLIA environment, relationships with strategic research and development partners, and access to specimens in our biobank.

ENDOinform, our highest pipeline development focus, is a multi-marker test program that combines serum proteins, clinical data (metadata), and miRNA for the identification of endometriosis. The test is being developed in collaboration with a consortium of academic and clinical partners led by Dana-Farber Cancer Institute. We are currently in the process of analyzing the first 180 patient samples to verify protein and miRNA biomarkers. These investigations will establish analytical properties on our droplet digital PCR commercial platform for miRNA detection. Additionally, this data set will provide information on initial disease classification capability of miRNA and proteins. This is a critical step in evaluating the strength of algorithms that incorporate miRNAs and proteins.
OVAinform is in the initial stages of development and is a multi-marker test that combines serum proteins, clinical data (metadata), and miRNA for assessing the risk of ovarian cancer in women with an adnexal mass, with an expanded indication of a surveillance tool for women determined to be at elevated risk of ovarian cancer due to genetic risk or a first degree relative with ovarian cancer. The test is being developed in collaboration with Harvard’s Dana-Farber Cancer Institute (providing clinical and trial design expertise), Brigham & Women’s Hospital (providing miRNA technical expertise), and Medical University of Lodz (providing miRNA biomarker and bioinformatics analytic support).

The miRNAs used in the OVAinform test were the subject of a 2017 paper, “Diagnostic potential for a serum miRNA neural network for detection of ovarian cancer” published in the peer-reviewed journal Cancer Biology. In November 2024 a peer review journal publication entitled “Serum miRNA improves the accuracy of a multivariate index assay for triage of an adnexal mass” was published by our collaborator Dr. Kevin Elias’ lab in the journal Gynecologic Oncology.  This paper demonstrated that the combination of miRNAs with serum protein biomarkers from Aspiras’s ovarian cancer risk tests provided superior performance over existing ovarian cancer risk assessment blood tests.

We have tested our entire set of selected miRNA biomarkers and, based on their performance, we are refining the features on our droplet digital PCR commercial platform. As a next step, we intend to increase our patient sample testing to refine the algorithm for the expanded utility of Ovainform.

Recent Developments

Business Updates

In the first quarter of 2025, we rebalanced the salesforce to align with profitable markets. This rebalance resulted in a reduction of field sales representatives in non-profitable markets. Under the rebalanced field team, we realized a 167% increase in sales per full-time equivalent salesperson in the third quarter of 2025, when compared to the third quarter of 2024. This rebalance was combined with a refresh of the variable compensation plan as well as a refresh of targeting strategies to maximize the efficiency and effectiveness of the sales team. These tactics included introduction of a new targeting platform, AcuityMD, to assist sales representatives in identifying highly profitable business, providers using off-label tests like CA-125, as well as obstetrician/gynecologists in markets with limited access to gynecological oncology specialists.

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The refresh of the variable compensation plan for the sales team consisted of a move away from compensation tied to volume and a move towards a compensation plan rooted in revenue. We believe this change in how we incentivize reps will steer better business and targeting by rewarding sales reps for selling business that is reimbursed well instead of compensating for selling business regardless of our ability to get paid.

As part of the targeting refresh, there has been a renewed focus on integrating with health systems as highlighted by a new health system utilizing OvaSuite beginning early in the third quarter of 2025. This health system began to implement a standardization in which every patient that is classified as Ovarian-adnexal Reporting and Data System (O-RADS) 4 was referred for an OvaSuite test. This solution was put into place to assist gynecologists in better identifying the high-risk patients out of a cohort of patients whose initial clinical assessment and ultrasound reading was indeterminate. Prior to this new strategy, this system was experiencing an over-referral of low-risk patients to the gynecological oncology team. By implementing our test, the health system was able to avoid additional imaging and reserve valuable gynecological oncology resources for the patients with true elevated risk for further evaluation of their mass by an oncologist.

As another example of our continued focus on selling one-to-many, the Dorsata Adnexal Mass Workflow module was released to the first large provider group in late June of 2025. The tool was made available to a provider group with approximately 300 obstetrician/gynecology providers. The goal of the tool is provide integrated care plans for adnexal mass risk management right in the Electronic Medical Record (“EMR”).  Within this workflow, our tests are surfaced as potential next steps, along with serial ultrasounds, referral to a gynecological oncologist and surgery. We believe this tool will be integral in our ability to surface our tests within provider’s workflows and continue to gain adoption across large networks of physicians.

On April 15, 2025, we were notified by the Office of General Counsel of The Nasdaq Stock Market (“Nasdaq”) indicating that the Nasdaq Hearings Panel has determined to delist our shares from Nasdaq due to our failure to meet Nasdaq’s continued listing standard under Nasdaq Listing Rule 5550(b)(1), which required us to maintain a minimum of $2.5 million in stockholders’ equity for continued listing on the Nasdaq Capital Market. Our common stock was traded on the OTC Markets Group effective at the open of trading on April 17, 2025 under the symbol “AWHL.” We successfully applied for trading on the OTC QB Venture Market effective May 7, 2025. We began trading on the OTC QX Best Market effective October 14, 2025.

On June 9, 2025, we received notice from ARPA-H that ARPA-H and the assigned managing contractor, VentureWell, have determined that we had not met the specifications of Milestone 3, and have therefore elected to terminate the contract award. We will continue to work on the design, development and commercial launch of this test.

Critical Accounting Estimates

There have been no material changes to our critical accounting estimates described in our Annual Report on Form 10-K, filed with the SEC on March 27, 2025.

Our product revenue is generated by performing diagnostic services using our OvaSuite tests, and the service is completed upon the delivery of the test result to the prescribing physician. The entire transaction price is allocated to the single performance obligation contained in a contract with a patient. Under ASC Topic 606, Revenue from Contracts with Customers, all revenue is recognized upon completion of the OvaSuite test and delivery of test results to the physician based on estimates of amounts that will ultimately be realized. In determining the amount of revenue to be recognized for a delivered test result, we consider factors such as payment history and amount, payer coverage, whether there is a reimbursement contract between the payer and us, and any developments or changes that could impact reimbursement. These estimates require significant judgment by management. For OvaSuite tests, we also review our patient account population and determine an appropriate distribution of patient accounts by payer (i.e., Medicare, patient pay, other third-party payer, etc.) into portfolios with similar collection experience. When evaluated for collectability, this results in a materially consistent revenue amount for such portfolios as if each patient account were evaluated on an individual contract basis.

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Results of Operations – Three Months Ended September 30, 2025 Compared to Three Months Ended September 30, 2024

The selected summary financial and operating data of the Company for the three months ended September 30, 2025 and 2024 were as follows.

    

Three Months Ended

    

Increase 

September 30, 

(Decrease)

(dollars in thousands)

2025

2024

Amount

%

Revenue:

 

  

 

  

 

  

 

  

Product

$

2,305

$

2,257

$

48

 

2

Total revenue

 

2,305

 

2,257

 

48

 

2

Cost of revenue:

 

  

 

  

 

  

 

  

Product

 

922

 

902

 

20

 

2

Total cost of revenue

 

922

 

902

 

20

 

2

Gross profit

 

1,383

 

1,355

 

28

 

2

Operating expenses:

 

  

 

  

 

  

 

  

Research and development

 

739

 

908

 

(169)

 

(19)

Sales and marketing

 

683

 

2,143

 

(1,460)

 

(68)

General and administrative

 

1,540

 

2,048

 

(508)

 

(25)

Total operating expenses

 

2,962

 

5,099

 

(2,137)

 

(42)

Loss from operations

 

(1,579)

 

(3,744)

 

2,165

 

(58)

Other (expense) income, net:

 

  

 

  

 

  

 

  

Change in fair value of warrant liabilities

 

(4,309)

 

174

 

(4,483)

 

(2,576)

Interest expense, net

 

(13)

 

(5)

 

(8)

 

160

Other income, net

 

1,009

 

28

 

981

 

3,504

Total other (expense) income, net

 

(3,313)

 

197

 

(3,510)

 

(1,782)

Net loss

$

(4,892)

$

(3,547)

$

(1,345)

 

38

Product Revenue. Product revenue was $2,305,000 for the three months ended September 30, 2025, compared to $2,257,000 for the same period in 2024. Revenue for Aspira Labs is recognized when the Ova1, Overa, Ova1Plus or OvaWatch test is completed based on estimates of what we expect to ultimately realize. The 2% product revenue increase is due to an increase in AUP, partially offset by a decrease in OvaSuite test volume compared to the prior year.

The number of OvaSuite tests performed decreased 5% to 5,727 during the three months ended September 30, 2025, compared to 6,001 product tests for the same period in 2024. This decrease is a result of our reduced field sales headcount. We expect revenue to increase in the fourth quarter due to our focus on revenue generating payers.

The volume and AUP for the three months ended September 30, 2025 and 2024 were as follows.

    

Three Months Ended

September 30, 

2025

2024

Product Volume:

Ova1Plus

 

4,473

 

4,708

OvaWatch

 

1,254

 

1,293

Total OvaSuite

 

5,727

 

6,001

Average Unit Price (AUP):

 

  

 

  

Ova1Plus

$

407

$

381

OvaWatch

 

384

 

360

Total OvaSuite

$

402

$

376

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Cost of Revenue – Product. Cost of product revenue was $922,000 for the three months ended September 30, 2025 compared to $902,000 for the same period in 2024, representing an increase of $20,000, or 2%.

Gross Profit Margin. Gross profit margin for product revenue remained consistent at 60.0% for the three months ended September 30, 2025, compared to the same period in 2024.

Research and Development Expenses. Research and development expenses represent costs incurred to develop our technology and carry out clinical studies, and include personnel-related expenses, regulatory costs, reagents and supplies used in research and development laboratory work, infrastructure expenses, contract services and other outside costs. Research and development expenses for the three months ended September 30, 2025 decreased by $169,000, or 19%, compared to the same period in 2024. This decrease was primarily due to a decrease in consulting costs of $204,000, personnel costs of $55,000 and lab supplies of $27,000, partially offset by an increase in clinical trial costs of $111,000. We expect research and development expenses to increase modestly over the fourth quarter of 2025, as a result of our focus on the product pipeline.

Sales and Marketing Expenses. Our sales and marketing expenses consist primarily of personnel-related expenses, education and promotional expenses. These expenses include the costs of educating physicians and other healthcare professionals regarding our products. Sales and marketing expenses also include the costs of sponsoring continuing medical education, medical meeting participation, and dissemination of scientific and health economic publications. Sales and marketing expenses for the three months ended September 30, 2025 decreased by $1,460,000, or 68%, compared to the same period in 2024. This decrease was primarily due to decreased personnel costs of $894,000, costs related to our contracted sales team of $235,000, travel costs of $188,000 and other marketing costs of $47,000 and decreased consulting costs of $37,000. We expect sales and marketing expenses to remain flat during the fourth quarter of 2025.

General and Administrative Expenses. General and administrative expenses consist primarily of personnel-related expenses, professional fees and other costs, including legal, finance and accounting expenses and other infrastructure expenses. General and administrative expenses for the three months ended September 30, 2025 decreased by $508,000, or 25%, compared to the same period in 2024. This decrease was primarily due to a decrease in personnel costs of $677,000 and board fees of $135,000, offset by an increase in legal fees of $220,000 and consulting costs of $54,000. We expect general and administrative expenses to decrease during the fourth quarter of 2025 as a result of decreases in our consulting and public company costs.

Change in fair value of Warrant Liabilities. For the three months ended September 30, 2025, there was a net increase in the Change in fair value of Warrant Liabilities of $4,084,000. The increase was due to the modification of the March 2025 Warrants, as well as the increase in our stock price during the quarter. For the three months ended September 30, 2024, there was a net decrease in fair value of $174,000. The change in fair value during the three months ended September 30, 2024 was primarily due to a decrease in our stock price during the quarter.

Other Income, net. For the three months ended September 30, 2025, there was a net increase in Other net income of $1,009,000. The increase was primarily due to the receipt of Employee Retention Tax Credits totaling $1 million. For the three months ended September 30, 2024, there was a net increase in Other net income of $28,000 related to the sale of equipment.

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Results of Operations – Nine Months Ended September 30, 2025 Compared to Nine Months Ended September 30, 2024

The selected summary financial and operating data of the Company for the nine months ended September 30, 2025 and 2024 were as follows.

Nine Months Ended

    

    

    

    

September 30, 

Increase (Decrease)

(dollars in thousands)

    

2025

    

2024

    

Amount

    

%

Revenue:

 

  

 

  

 

  

 

  

Product

$

6,988

$

6,833

$

155

 

2

Total revenue

 

6,988

 

6,833

 

155

 

2

Cost of revenue:

 

  

 

  

 

  

 

  

Product

 

2,511

 

2,843

 

(332)

 

(12)

Total cost of revenue

 

2,511

 

2,843

 

(332)

 

(12)

Gross profit

 

4,477

 

3,990

 

487

 

12

Operating expenses:

 

  

 

  

 

  

 

  

Research and development

 

2,416

 

2,766

 

(350)

 

(13)

Sales and marketing

 

2,448

 

6,169

 

(3,721)

 

(60)

General and administrative

 

6,242

 

7,902

 

(1,660)

 

(21)

Total operating expenses

 

11,106

 

16,837

 

(5,731)

 

(34)

Loss from operations

 

(6,629)

 

(12,847)

 

6,218

 

(48)

Other income (expense), net:

 

  

 

  

 

  

 

  

Change in fair value of warrant liabilities

 

(4,012)

 

1,314

 

(5,326)

 

(405)

Change in fair value of convertible notes

170

-

170

 

-

Loss upon issuance of Convertible Notes carried at fair value

(1,198)

-

(1,198)

 

-

Interest expense, net

 

(40)

 

(20)

 

(20)

 

100

Other income (expense), net

 

2,298

 

(153)

 

2,451

 

(1,602)

Total other (expense) income, net

 

(2,782)

 

1,141

 

(3,923)

 

(344)

Net loss

$

(9,411)

$

(11,706)

$

2,295

 

(20)

Product Revenue. Product revenue was $6,988,000 for the nine months ended September 30, 2025, compared to $6,833,000 for the same period in 2024. The 2% product revenue increase is due to an increase in AUP, offset by a decrease in OvaSuite test volume compared to the prior year.

The number of OvaSuite tests performed decreased 6% to 17,134 during the nine months ended September 30, 2025, compared to 18,301 product tests for the same period in 2024. This decrease is a result of our reduced field sales headcount.

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The volume and AUP for the nine months ended September 30, 2025 and 2024 were as follows.

Nine Months Ended

September 30, 

    

2025

    

2024

Product Volume:

 

  

 

  

Ova1Plus

 

13,282

 

14,649

OvaWatch

 

3,852

 

3,652

Total OvaSuite

 

17,134

 

18,301

Average Unit Price (AUP):

 

  

 

  

Ova1Plus

$

412

$

379

OvaWatch

 

393

 

349

Total OvaSuite

$

408

$

373

Cost of Revenue – Product. Cost of product revenue was $2,511,000 for the nine months ended September 30, 2025 compared to $2,843,000 for the same period in 2024, representing a decrease of $332,000, or 12%, due primarily to a one-time credit related to phlebotomy expenses and decreased personnel costs, partially offset by an increase in consulting costs.

Gross Profit Margin. Gross profit margin for product revenue increased to 64.1% for the nine months ended September 30, 2025, compared to 58.4% for the same period in 2024.

Research and Development Expenses. Research and development expenses for the nine months ended September 30, 2025 decreased by $350,000, or 13%, compared to the same period in 2024. This decrease was primarily due to a decrease in consulting costs of $530,000 and personnel costs of $210,000, partially offset by an increase in clinical trial costs of $492,000.

Sales and Marketing Expenses. Sales and marketing expenses for the nine months ended September 30, 2025 decreased by $3,721,000, or 60%, compared to the same period in 2024. This decrease was primarily due to decreased personnel costs of $2,140,000, costs related to our contracted sales team of $707,000, travel costs of $504,000 and other marketing costs of $207,000.

General and Administrative Expenses. General and administrative expenses for the nine months ended September 30, 2025 decreased by $1,660,000, or 21%, compared to the same period in 2024. This decrease was primarily due to a decrease in personnel costs of $1,971,000 and legal fees of $384,000, partially offset by an increase in consulting costs of $487,000 and audit fees of $249,000.

Change in fair value of Warrant Liabilities. For the nine months ended September 30, 2025, there was a net increase in the Change in fair value of Warrant Liabilities of $3,787,000. The increase was due to the modification of the March 2025 Warrants, as well as the increase in our stock price during the year. For the nine months ended September 30, 2024, there was a net decrease in fair value of $233,000. The change in fair value during the nine months ended September 30, 2024 was primarily due to a decrease in our stock price during the quarter.

Change in fair value of Convertible Notes. The change in fair value of Convertible Notes for the nine months ended September 30, 2025 was $170,000, which was the gain recognized upon the conversion of the Convertible Notes.

Loss upon issuance of Convertible Notes carried at fair value. The loss upon issuance of Convertible Notes carried at fair value for the nine months ended September 30, 2025 was $1,198,000. This represents an immediate loss recognized by the Company upon the issuance of the Convertible Notes.

Other Income, net. For the nine months ended September 30, 2025, there was a net increase in Other net income of $2,298,000. The increase was primarily due to the receipt of $1,500,000 from ARPA-H and the receipt of Employee Retention Tax Credits totaling $1,013,000. For the nine months ended September 30, 2024, there was a net decrease in

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Other net income of $153,000, primarily due to $113,000 of the cost of the 2024 Registered Direct Offering that was allocated to the modification of the August 2022 Warrants.

Liquidity and Capital Resources

We plan to continue to expend resources selling and marketing OvaSuite and developing additional diagnostic tests and service capabilities.

We have incurred significant net losses and negative cash flows from operations since inception, and as a result have an accumulated deficit of approximately $540,808,000 as of September 30, 2025. We also expect to incur a net loss and negative cash flows from operations for the remainder of 2025. Working capital levels may not be sufficient to fund operations as currently planned through the next twelve months, absent a significant increase in revenue over historic revenue or additional financing. Given the above conditions, there is substantial doubt about our ability to continue as a going concern within one year after the date these consolidated interim financial statements are filed.

We expect to raise capital through sources that may include public or private equity offerings, debt financings, the exercise of common stock warrants, collaborations, licensing arrangements, grants and government funding and strategic alliances, as well as our existing at-the-market and equity line of credit facilities. However, additional funding may not be available when needed or on terms acceptable to us. If we are unable to obtain additional capital, we may not be able to continue sales and marketing, research and development, or other operations on the scope or scale of current activity, and that could have a material adverse effect on our business, results of operations and financial condition.

In March 2016, we entered into a loan agreement (as amended on March 7, 2018 and April 3, 2020, the “DECD Loan Agreement”) with the State of Connecticut Department of Economic and Community Development (the “DECD”), pursuant to which we borrowed $4,000,000 from the DECD.

Under the terms of the DECD Loan Agreement, we were eligible for forgiveness of $1,500,000 of the principal amount of the loan after achieving certain job creation and retention milestones. If we fail to maintain our Connecticut operations through March 22, 2026, the DECD may require early repayment of a portion or all of the loan plus a penalty of 5% of the total funded loan. For additional information, see Note 5 to our unaudited condensed consolidated financial statements. If we choose to repay the loan early, it may be done at any time without premium or penalty.

On March 28, 2023, we entered into a purchase agreement (the “2023 Equity Line of Credit Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”) and a registration rights agreement (the “LPC Registration Rights Agreement”), pursuant to which we have the right, in our sole discretion, to sell to Lincoln Park shares of our common stock, par value $0.001 per share, having an aggregate value of up to $10,000,000 (the “Purchase Shares”), subject to certain limitations and conditions set forth in the 2023 Equity Line of Credit Agreement. We control the timing and amount of any sales of Purchase Shares to Lincoln Park pursuant to the 2023 Equity Line of Credit Agreement.

During the three and nine months ended September 30, 2025, we sold no shares under the 2023 Equity Line of Credit Agreement, respectively. During the three and nine months ended September 30, 2024, we sold 362,219 and 949,574 shares under the 2023 Equity Line of Credit Agreement, respectively; resulting in gross proceeds of approximately $400,000 and $1,900,000, respectively. Over the life of the 2023 Equity Line of Credit Agreement through August 8, 2025, we sold 1,310,517 shares for gross proceeds of approximately $3,078,000. We incurred approximately $326,000 in costs related to the execution of the 2023 Equity Line of Credit Agreement, all of which are reflected in the unaudited condensed consolidated financial statements. Of the total costs incurred, approximately $258,000 was paid in common stock to Lincoln Park for a commitment fee and $30,000 was paid for Lincoln Park expenses. These transaction costs were included in other expense in our consolidated statement of operations for the year ended December 31, 2023. We incurred approximately $0 and $249,000 for legal fees during the nine months ended September 30, 2025 and 2024, respectively, and included the costs in general and administrative expenses on its consolidated statement of operations. Under the terms of the Warrant Inducement Agreement, we agreed not to sell shares under the 2023 Equity Line of Credit Agreement for six months from the effective date of the Form S-3, which was September 3, 2024. As of November 8, 2025, the remaining availability under the 2023 Equity Line of Credit Agreement was $1,700,000 of shares of common stock that can be sold

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to Lincoln Park under the 2023 Equity Line of Credit Agreement; however, as we are no longer traded on Nasdaq, we do not have access to this facility.

On January 24, 2024, we entered into a securities purchase agreement (the “2024 Direct Offering Agreement”), with several investors relating to the issuance and sale of 1,371,000 shares of its common stock, par value $0.001 per share, and pre-funded warrants to purchase 200,000 shares of common stock (the “Pre-Funded Warrants”), in a registered direct offering, together with accompanying warrants to purchase 1,571,000 shares of common stock (the “Purchase Warrants”, and together with the Pre-Funded Warrants, the “2024 Warrants”) in a concurrent private placement (the “Concurrent Private Offering” and together with the registered direct offering, the “2024 Direct Offering”). Our gross proceeds from the 2024 Direct Offering were approximately $5.6 million, before deducting placement agent fees and other expenses of $694,000 payable by us.

The Pre-Funded Warrants were exercised on February 6, 2024 for $20.

The Purchase Warrants have an exercise price of $4.13 per share and will expire 5 years from the initial issuance date.

Effective upon the closing of the 2024 Direct Offering, we also amended certain existing warrants to purchase up to an aggregate of 366,664 shares at an exercise price of $13.20 per share and a termination date of August 25, 2027, so that the amended warrants have a reduced exercise price of $4.13 per share and a new termination date of January 26, 2029. The other terms of the amended warrants remain unchanged.

On October 23, 2024, the Advanced Research Projects Agency for Health (“ARPA-H”) announced that we had been selected as an awardee of the Sprint for Women’s Health. We would receive up to $10,000,000 in funding over two years through the Sprint for Women’s Health launchpad track for later-stage health solutions. We would receive payments based on the completion of certain agreed-upon milestones.

We met the first milestone for payment in the fourth quarter of 2024 and received a payment of $2,000,000. The second milestone was met during the first quarter of 2025 and we received a payment of $1,500,000. On June 9, 2025, we received notice from ARPA-H that ARPA-H and the assigned managing contractor, VentureWell, have determined that we had not met the specifications of the third milestone, and have therefore elected to terminate the ENDOinform development program contract.

On March 5, 2025, we entered into a securities purchase agreement with certain existing accredited shareholders (“the “Purchasers”) for the issuance and sale in a private placement (the “March 2025 Private Placement”) of an aggregate gross principal amount of $1,365,500 in the form of Senior Secured Convertible Promissory Notes (the “Convertible Notes”). On March 12, 2025, the Convertible Notes were converted into 5,465,850 shares and warrants to purchase 12,298,177 shares (the “March 2025 Warrants”).

The March 2025 Warrants were exercisable for five years at $0.25 per share for the first 24 months after issuance, and $0.50 per share thereafter. In September 2025, the March 2025 Warrants were amended to have an exercise price of $0.35 and an expiration date of March 5, 2031.

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As mentioned, we have incurred significant net losses and negative cash flows from operations since inception, and we expect to continue to incur a net loss and negative cash flows from operations in 2025. At September 30, 2025 we had an accumulated deficit of $540,808,000 and stockholders’ deficit of $4,344,000. As of September 30, 2025, we had $3,809,000 in cash and cash equivalents, $4,199,000 in current liabilities, and working capital of $1,626,000. There can be no assurance that we will achieve or sustain profitability or positive cash flow from operations. While we expect to grow revenue through Aspira Labs, there is no assurance of our ability to generate substantial revenues and cash flows from Aspira Labs’ operations. We expect revenue from our products to be our only material, recurring source of cash for the remainder of 2025.

Our future liquidity and capital requirements will depend upon many factors, including, among others:

resources devoted to sales, marketing and distribution capabilities;
the rate of OvaSuite product adoption by physicians and patients;
the rate of product adoption by healthcare systems and large physician practices of the decentralized distribution agreements for OvaSuite;
the insurance payer community’s acceptance of and reimbursement for our products;
our plans to acquire or invest in other products, technologies and businesses; and
the potential need to add study sites to access additional patients to maintain clinical timelines.

Net cash used in operating activities was $5,048,000 for the nine months ended September 30, 2025, resulting primarily from the net loss reported of $9,411,000, which includes changes in the fair value of warrant liabilities of $4,012,000, the loss upon issuance of Convertible Notes carried at fair value of $1,198,000, changes in prepaid assets of $670,000, non-cash lease expense of $158,000 and $155,000 in stock based compensation expense, offset by changes in other liabilities of $613,000, changes in accrued liabilities of $478,000, changes in accounts payable of $362,000, changes in accounts receivable of $327,000 and a $170,000 change in the fair value of Convertible Notes carried at fair value.

Net cash used in operating activities was $11,092,000 for the nine months ended September 30, 2024, resulting primarily from the net loss reported of $11,706,000, which includes non-cash expenses in the amount of $1,290,000 related to changes in accounts payable, stock compensation expense of $864,000 and $560,000 related to changes in prepaid expense offset by $1,314,000 relating to a change in fair value of warrant fair value and changes in other liabilities of $369,000.

Net cash used in investing activities was $393,000 and $37,000 for the nine months ended September 30, 2025 and 2024, respectively, which consisted primarily of intangible asset purchases.

Net cash provided by financing activities was $7,533,000 for the nine months ended September 30, 2025, stemming primarily from the at the market offering resulting in net proceeds of $3,337,000, from a private placement offering resulting in net proceeds of $2,815,000 and from convertible notes resulting in gross proceeds of $1,366,000, in addition to $112,000 from the exercise of warrants, offset by principal payments on the DECD loan.

Net cash provided by financing activities was $10,407,000 for the nine months ended September 30, 2024, stemming primarily from a registered direct offering resulting in net proceeds of $4,830,000, after deducting placement agent costs and other expenses of $733,000, and an equity line of credit offering of $1,901,000.

Based on the available objective evidence, we believe it is more likely than not that net deferred tax assets will not be fully realizable. Accordingly, we have provided a full valuation allowance against our net deferred tax assets. Therefore, there was no deferred income tax expense or benefit for the period.

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Our pre-2018 federal NOLs will expire in varying amounts from 2023 through 2037, if not utilized, and can offset 100% of future taxable income for regular tax purposes. Any federal NOLs arising after January 1, 2018, can generally be carried forward indefinitely but such federal NOL carryforwards are permitted to be used in any taxable year to offset up to 80% of taxable income in such year. Portions of our state NOLs will expire in varying amounts from 2023 through 2037 if not utilized. Our ability to use our NOLs during this period will be dependent on our ability to generate taxable income, and the portions of our NOLs could expire before we generate sufficient taxable income.

Our ability to use our net operating loss and credit carryforwards to offset future taxable income is restricted due to ownership change limitations that have occurred in the past, as required by Section 382 of the Internal Revenue Code of 1986, as amended (“Section 382”), as well as similar state provisions. Net operating losses which are limited from offsetting any future taxable income under Section 382 are not included in the gross deferred tax assets. Due to the existence of a valuation allowance, it is not expected that such limitations, if any, will have an impact on our results of operations or financial position.

Our unrecognized tax benefits attributable to research and development credits will increase during the period for tax positions taken during the year and will decrease for expiration of a portion of the carryforwards during the period.

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Per Item 305(e) of Regulation S-K, the information called for by this Item 3 is not required.

ITEM 4. CONTROLS AND PROCEDURES

Evaluation of disclosure controls and procedures

Our senior management is responsible for establishing and maintaining a system of disclosure controls and procedures (as defined in Rule 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by an issuer in the reports that it files or submits under the Exchange Act is accumulated and communicated to the issuer’s management, including its principal executive officer and principal financial officer, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.

Management, including our Chief Executive Officer and Controller, performed an evaluation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of September 30, 2025. Based on this evaluation, our Chief Executive Officer and Controller have concluded that as of September 30, 2025, our disclosure controls and procedures were not effective. This was due to a material weakness in the internal control over financial reporting that was identified as of December 31, 2024, and disclosed in our 2024 Annual Report Form 10-K related to the operation of internal controls related to our contract review processes and the accounting for such contracts that continue to exist as of September 30, 2025.

Material Weakness

As previously reported, we identified a material weakness related to the accounting for complex financial transactions, including the technical accounting conclusions reached. During the year ended December 31, 2024, we entered into two transactions that were considered to be significant, non-routine or complex transactions, including a warrant inducement and a government grant. While the control was adequately designed, the operation of the control was not effective for either transaction.

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Remediation Activities

In order to address material weakness in internal control over financial reporting as of December 31, 2024, previously disclosed, management implemented remediation activities, with direction from the audit committee. The activities that we have taken include retaining outside accounting assistance from a nationally recognized firm for certain significant, non-routine or complex transactions, including warrant valuation, beginning in the first quarter of 2025.

Limitations on Effectiveness of Controls and Procedures and Internal Control over Financial Reporting

In designing and evaluating the disclosure controls and procedures and internal control over financial reporting, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. In addition, the design of disclosure controls and procedures and internal control over financial reporting must reflect the fact that there are resource constraints, and that management is required to apply judgment in evaluating the benefits of possible controls and procedures relative to their costs.

Changes in internal controls over financial reporting

Other than as described above, there were no changes in our internal control over financial reporting during the three months ended September 30, 2025 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

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PART II – OTHER INFORMATION

ITEM 1. LEGAL PROCEEDINGS

In the ordinary course of business, we may periodically become subject to legal proceedings and claims arising in connection with ongoing business activities. The results of litigation and claims cannot be predicted with certainty, and unfavorable resolutions are possible and could materially and adversely affect our results of operations, cash flows and financial position. In addition, regardless of the outcome, litigation could have an adverse impact on us because of defense costs, diversion of management resources and other factors. While the outcome of these proceedings and claims cannot be predicted with certainty, there are no matters, as of September 30, 2025, that, in the opinion of management, will have a material adverse effect on our financial position, results of operations or cash flows.

ITEM 1A. RISK FACTORS

Except as set forth below, there have been no material changes to our risk factors from those disclosed under “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 27, 2025 (the “2024 Annual Report”) and in Part II, Item 1 of our Quarterly Report on Form 10-Q, for the quarter ended March 31, 2025 (the “March 31, 2025 Quarterly Report”), filed with the SEC on May 19, 2025. The risks and uncertainties described in our 2024 Annual Report and the March 31, 2025 Quarterly Report are not the only ones we face. Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also materially adversely affect our business, financial condition or results of operations. We may disclose changes to such factors or disclose additional factors from time to time in our future filings with the SEC.

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.

There were no sales of equity securities during the period covered by this report that were not registered under the Securities Act and were not previously reported in a Current Report on Form 8-K filed by the Company.

ITEM 3. DEFAULTS UPON SENIOR SECURITIES.

None.

ITEM 4. MINE SAFETY DISCLOSURES.

Not applicable.

ITEM 5. OTHER INFORMATION

None.

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ITEM 6. EXHIBITS

The following exhibits are filed or incorporated by reference with this report as indicated below:

 

 

 

 

Incorporated by Reference

 

 

Exhibit

 

 

 

 

 

 

 

Filing

 

Filed

Number

    

Exhibit Description

 

Form

 

File No. 

 

Exhibit 

 

Date

 

Herewith

4.1

Form of Warrant, issued on September 17, 2025

8-K

001-34810

4.1

September 18, 2025

4.2

Form of Amended and Restated Warrant, issued on September 19, 2025

8-K/A

001-34810

4.1

November 3, 2025

10.1

Master Services Agreement between Aspira Women’s Health Inc. and Brian Hungerford, dated September 2, 2025

8-K

001-34810

10.1

September 3, 2025

10.2

Statement of Work by and between Aspira Women’s Health Inc. and Brian Hungerford, dated September 2, 2025

8-K

001-34810

10.2

September 3, 2025

10.3

Form of Securities Purchase Agreement, dated September 17, 2025

8-K

001-34810

10.1

September 18, 2025

10.4

Form of Amendment to Securities Purchase Agreement, dated September 19, 2025

8-K

001-34810

10.1

September 25, 2025

31.1

 

Certification of the Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 

 

 

 

 

 

 

 

 

31.2

 

Certification of the Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 

 

 

 

 

 

 

 

 

32.1**

 

Certification of the Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 

 

 

 

 

 

 

 

 

√√

101.INS

 

Inline XBRL Instance Document - (the instant document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document).

 

 

 

 

 

 

 

 

 

101.SCH

 

Inline XBRL Taxonomy Extension Schema with Embedded Linkbase Documents

 

 

 

 

 

 

 

 

 

104

 

Cover page formatted as Inline XBRL and contained in Exhibit 101

 

 

 

 

 

 

 

 

 

√ Filed herewith

√√ Furnished herewith

*

Management contract or compensation plan or arrangement.

**

The certification attached as Exhibit 32.1 that accompany this Quarterly Report on Form 10-Q, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of this Form 10-Q), irrespective of any general incorporation language contained in such filing.

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

Aspira Women’s Health Inc.

 

 

Date: November 14, 2025

/s/ Michael Buhle

 

Michael Buhle

Chief Executive Officer

(Principal Executive Officer)

 

 

Date: November 14, 2025

/s/ Brian Hungerford

Brian Hungerford

Chief Financial Officer

 

(Principal Financial Officer and Principal Accounting Officer)

45

FAQ

What were AWHL’s Q3 2025 revenues and net loss?

Revenue was $2,305,000 and net loss was $4,892,000.

How did non-cash items affect AWHL’s Q3 2025 results?

A change in fair value of warrant liabilities produced a $4,309,000 non-cash loss, materially impacting the quarter.

What is Aspira Women’s Health’s cash position?

Cash and cash equivalents were $3,809,000 as of September 30, 2025.

Did AWHL raise capital in 2025?

Yes. Gross proceeds were $3,484,000 from the 2024 ATM and $2,949,000 from a September 2025 private placement.

What is the status of AWHL’s listing?

Shares were delisted from Nasdaq in April 2025 and began trading on the OTC QX Best Market on October 14, 2025.

What guidance did AWHL give on going concern?

The company stated substantial doubt about its ability to continue as a going concern within one year.

How many shares are outstanding?

There were 42,655,918 shares outstanding as of November 13, 2025.
Aspira Womens Health Inc

OTC:AWHL

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AWHL Stock Data

16.05M
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Diagnostics & Research
Healthcare
Link
United States
Austin